“AYOBA” - the real Kwaito is back with EES & Mandoza

The First single from the new EES hit album was just released last Friday, and already the southern Africa is responding overwhelming with massive positive feedback! We wanted to get the Namibian media as close as possible to this massive step for NAM music outside the border – with special pictures and video media!

Having spent the last eight years using his German roots to represent Kwaito in Europe, Namibian born artist EES is no beginner. In fact, he is quite the opposite. He has been nominated for the MTV Europe Rookie Award (2008), has won the MTV Africa Listener's Choice Award and was voted Namibian Artist of the Year (2009). With the upcoming release of his 9th studio album, Megaphone Ghazzie, EES is ready to bring back the pure Kwaito energy and rhythm that is his passion. The album is due to be released on 7th October 2011.

The first single off the album will be the hit track “Ayoba” featuring South African Kwaito sensation Mandoza. It was in May when EES, just back from recording and touring in Europe, met up with Mandoza in Cape Town to work on the collaboration. The two artists not only laid down the vocals for the track, but also featured together in the music video for the song produced by Cape Town based One Shot Films.

The song “Ayoba” is all about the celebration of life and though it was initially meant to be a pure party track, the collaboration between the artists re-shaped it into something more spiritual. This is reflected in the video as we follow EES through the harsh desert until he meets Mandoza on a rooftop in of a big metropolis city where they join voices to share their celebration with the city and the world. Don't let that fool you into thinking it's not going to make you get up and dance though. I guarantee that when you hear the track, you'll want to turn up the volume, grab your converse and hit the party with all the love you've got.

The artists had the following to say about the experience:

Mandoza:  “it was great to finally meet EES as we have been discussing the collaboration for a while. He is talented and very focused in what he does and is exactly the type of artist I love working with. I thank the Almighty for giving me the opportunity once again to represent South Africa in other countries!”

EES:  “It was an amazing experience to collaborate with an artist as powerful as Mandoza, I have followed his music for years and I was determined to one day have the opportunity to do a song with him. That voice! Wow!”

EES has been working hard for the past 8 years at making a name for himself internationally and has found the European community to be very open to his Kwaito rhythms and style. The work is paying off. EES is surely a star on the rise.

 

EES feat. Mandoza – “Ayoba” MUSIC VIDEO

 

EES - ("Ayoba" feat. Mandoza) TEASER

THE MAKING OF VIDEO

EES – New Album TEASER Video

 

The new EES album "Megaphone Ghazzie!"
in stores nationwide and available for online download at:

    

Gecko heat dies down

GECKO Namibia has pledged not to go ahead with a multi-billion- dollar industrial park and port development at Swakopmund if it is proven that the health of people and the environment will be compromised.

During a public talk held in Windhoek on Wednesday night, Gecko Namibia, which is in the process of investigating the viability of developing three chemical acid plants, a harbour, salt mine and desalination plant in the Erongo Region, vowed to undertake the “most comprehensive” environmental impact assessment ever undertaken in Namibia. 
The proposed plans for the controversial development have caused widespread concern that the industrial park will permanently scar and destroy Swakopmund’s skyline and its surrounding area, in particular the recently proclaimed Dorob National Park. Concerns are that tourism and the unique biodiversity of the region will suffer as a consequent of squeezing in a major chemical plant in an area renowned for environmental integrity.
While the site and the size of Vision Industrial Park’s (VIP) proposed development is highest on the discussion list between Gecko and those opposed to the project, other issues clock in closely behind.
These issues include fears of the toxic by-products produced by the planned plants, which will harm the health of people and the environment, both on land and in the Atlantic Ocean.
Philip Ellis, Gecko’s managing director for Namibia, told a large group of residents concerned with the more than N$12 billion development, that the company “can assure you we will not take short- cuts” during any of the preliminary scoping and assessment phases which are required by Namibian law.
Peter Tarr, Executive Director at the Southern African Institute for Environmental Assessment (SAIEA), the company which is independently investigating the impact the planned VIP project will have on the environment, including the towns and people in the vicinity of the plant, said at the meeting that “Gecko have stated they will walk away from the process if the Environmental Impact Assessment (EIA) shows the negative impacts cannot be mitigated”. Tarr said it is vital that the public hold Gecko to that promise.
According to a participant of the Wednesday night meeting, hosted by the Namibian Environment and Wildlife Society (News), the emotional heat with which the project has been criticised and questioned to date is shifting and growing less volatile.
“It was very controlled and it went very well. People were not up in arms. There was a certain amount of integrity”, a participant said. 
The participant pointed out that the debate is calming down because “people now understand better. The problem was, they didn’t understand.”
Peter Cunningham, a member of News who chaired the meeting, said that the process around the development, including the fact that the plans still need to undergo extensive impact assessments before any green light will be given, has calmed people down.
“It is not a done deal. People are starting to understand it.” Cunningham welcomed the heated debate around the VIP, which he says has opened up a vein of discussion around environmental issues causing people to lose their “apathy”. 
“People are just not involved enough. This is making people aware of environmental issues. That is a good thing”, he said.
Many argue that the industrial park belongs in or close to Walvis Bay, which is already viewed as an industrial hub – plus the fact that it is home to Namibia’s biggest port.
But Pine Van Wyk, the head of engineering and project director of Gecko Namibia, explained at the meeting that “if you run financial models for Walvis Bay, we don’t have a project. At those sort of expenses, we simply don’t have a project”.
According to Gecko, the most viable sites for the proposed 4 000 hectare property lie north of Swakopmund. 
Essentially many want to know whether the benefits of the park will outweigh the possible negatives, or vice versa.
According to Gecko, the “uranium rush” lends itself to an enterprise which locally produces and supplies essential chemicals needed to process raw uranium ore.
“Vision Park is linking itself to the uranium rush as a service provider and value adder,” Tarr said.
In addition, Gecko has stated that the construction and post-construction phases will create massive employment. In view of the fact that Namibia has a reported unemployment rate topping 50 per cent, Ellis said “if Namibia needs anything, it is jobs”.
Gecko Namibia stated that 95 per cent or more of the close to 2 500 permanent jobs the completed plant will be able to offer, will be filled by Namibian citizens.

Sensing Something ... About the Census

Ihave not been counted! And I so desperately wanted to be amongst those exclusive and elusive few that refused to be counted, but since no-one showed up, I was forced to join the larger group.

I found the whole experience underwhelming and in bad taste to say the least. Not even the extension of the deadline gave me the relief I almost prayed for.
I am disgusted by the poor planning of the entire thing. There were holes in some of the maps, probably leftovers from the last census. What, they could not buy new ones? Couldn’t they at least have covered the holes with masking tape?
And a lot of the expected households did not RSVP. I hear that was due to privacy concerns and homelessness. The work started late and slowly despite the provision of cars and helicopters.
This despite the fact that they had ten years to plan for this.
Granted, it is not easy counting people. They have a habit of not staying put. Try counting the people at a party. The first thing you will find out is that some have inexplicably disappeared.
But still, ten years and they are struggling with the basics?
The NPC also failed to make extra keys for locked farm gates. Given the love/hate relationship we have with our commercial farmers, you’d think they would plan for this. Or did they just simply fail to make an appointment? How about sending a simple e-mail?
The ‘dogs’ issue was another headache. So much for being man’s best friend.
Either way, not only did the NPC fail to provide protective gear against attacks, there were not enough toilet facilities in case those damned animals decided to give chase. Merely giving them t-shirts and caps is hardly adequate.
Is that the way to take care of our enumerators? Why couldn’t they buy those suits dog trainers wear? Brown jeans?
Not that the enumerators have anything to gloat about. Some of them messed up basic questions because they could apparently not understand them.And since the supervisors were outside, watching the car, nobody could help them. As a result some apparently ended up counting
themselves as well. They did not have a problem counting their money, if memory serves me right. They can tell you to the last cent how much they are owed. But they miss something as big as a house.
No wonder there were threats made against them.
Not that they have anything to fear in this respect. The police are onto this as well as issues of non-compliance. Enumerators claim 67 people refused to be counted, possibly more.
These are pretty accurate figures. Why didn’t they just write those numbers down?
The real disgusting thing was the attitude of some of the NPC people. Whenever a complaint was leveled against them, they had a ready made excuse. And
they did not look guilty at all! As a matter of fact, they seemed relaxed and in high spirits all the time.
It is clear that they had forgiven themselves. Should forgiveness not come from us? I prefer guilty people who look guilty and feel bad. Has screwing up become that common and acceptable?
I must admit it is not entirely the fault of the NPC that I was not counted. There was a bit of complacency on my part. I was standing under a tree when two enumerators walked past me. A tree is not a house. Plus, I completely forgot to bring my shack with me. But I brought my dog and the bedpan I stole at the Katutura hospitalduringthepoweroutage.Andyou know what they say about enumerators, dogs and toilet facilities ...

Privatisation of communal land in the North gaining momentum

TENSION is brewing in the communal farming area of Omakango, east of Okongo in the Ohangwena Region, where ‘politically connected’ individuals have allegedly fenced off large tracts of grazing land.

The farmers who claim to have been affected are from the farming areas of Omupanda, Oiti Itoka, Ombwa yOmamanya, Ombwa yOmuuva, Ombwa yOmunghete, Odjele and Oshuudiya. 
Apart from illegal fencing there is an additional dispute about whether these areas fall under the Ondonga or Oukwanyama traditional authority.
The actions of the ‘politically connected’ farmers contravene the Communal Land Reform Act, which prohibits fencing of communal land without permission.
However, it has emerged that the fenced-off land ‘belongs’ to Tileinge Hapulile, who is said to have enclosed the land before the enactment of the Communal Land Reform Act.
The affected farmers have now threatened unspecified action to remove the fence to open up pasture for their animals.
One of the affected farmers who alerted The Namibian to the issue said that at least 4 000 to 5 000 head of cattle have been denied grazing because of Hapulile’s enclosure of communal land.
About 50 cattle are alleged to have died of hunger, because many farmers have to scavenge for grazing on mostly barren communal land.
The communal farming area east of Okongo has seen unprecedented settlement, mainly by communal farmers from the Ohangwena and Oshikoto regions in the 1990s, some of whom started fencing off land.
The affected farmers say the settlers of the 1990s claimed that they were given permission by the Oukwanyama Traditional Authority to settle in Omakango.
But the new entrants, who include Namibia Diamond Trading Company managing director Shihaleni Ellis Ndjaba, were allegedly given permission by Tileinge Hapulile, who claims to be the headman of the area. 
He claims to have been given such authority by the Ondonga Traditional Authority.
“With his newfound capacity and self-accorded powers, Hapulile started giving ‘permission’ and allocating pieces of land to several new entrants, who wasted no time in constructing their fences at an unprecedented scale,” says one concerned farmer, speaking on condition of anonymity.
Ndjaba says he did nothing wrong as he was simply accommodated in a farming area  already fenced off by Hapulile.
“This is not something new. I know there have been people complaining about this issue but the fences were put before the Communal Land Reform Act. We are only accommodated inside the farm,” says Ndjaba.
The spokesperson of the Oukwanyama Traditional Authority, Andreas Naikaku, says  the Omakango issue is in the hands of the Ohangwena Police and the Ministry of Lands and Resettlement.
The secretary of Ondonga Traditional Authority, Joseph Asino, says the matter is news to the authority.
“If it was reported to the authority it was reported here through different channels. Unless perhaps we would make investigations to find out from Hapulile whether such claims have truth or not,” Asino says.
In terms of Communal Land Act, the erection of fences is restricted to homesteads, cattle pens, water troughs, and crop fields in communal areas.
The Act makes the erection of fences without proper authorisation a criminal offence punishable by a maximum N$4 000 fine or one year’s imprisonment or both.

Elephants face uphill battle

THE shooting of a female elephant in the Hoarusib River in the Kunene Region has alarmed conservationists and scientists about the future of the desert-dwelling jumbos.

The poaching is being investigated by the Ministry of Environment and Tourism and  the Protected Resources Unit of the Namibian Police. The carcass was found by tour guides in the Hoarusib River, four kilometres downriver from the Purros settlement, on Sunday, September 11. 
The deputy Director of Wildlife Management at the ministry, Colgar Sikopo, said the “investigation is a difficult one”. He said at least two bullets killed the young female and it is unclear whether the motivation was self-defence or poaching. 
Sources in the tourist sector claim that the elephant was found with between four and six bullet wounds.
The death of the elephant comes only weeks after another female was killed by Government officials. The tuskless female was declared a problem animal following a fatal attack on a Spanish tourist at the Purros Conservancy rest camp.
A source in the tourist trade said the tragic event was not surprising.
He said during this time of the year, the tourism high season, “elephants are under continuous pressure” from the large number of tourists who travel through the area. He said the particular group of elephants were “disturbed by the self-drives which caused them to get agitated”. 
The shooting of the female sub-adult only a few weeks later has sparked concern that the drastic reduction of breeding females could permanently harm the chances of the desert elephants to thrive in the Kunene Region.
A tour guide, who preferred to remain anonymous due to the sensitive nature of the issue, said there are now only 12 or fewer breeding females left in the area.
“It is hugely concerning and really puts elephant conservation back a great deal. I’m not sure it’s even a viable population any longer.” 
Sikopo dismissed these concerns, however, and said the ministry is not worried about the “sex ratio ... right now”. He said the number one concern is “the killing of an elephant in this manner”.
Sikopo said it is critical that the investigation continues and that a culprit is apprehended. He said there “is no reason to panic at this stage” but the ministry will keep a close eye on the area and will take action if similar illegal incidents continue.
Research published in the scientific journal pachydermjournal.org this year highlighted the danger a sudden decrease in breeding females could have on the Kunene desert elephants. 
Research showed that around 70 elephants occupied the Hoarusib River in the late 1970s.
Between 1975 and 1979 the elephant population declined drastically due to poaching. By 2009, it was estimated only 14 adult female elephants remained in the Kunene Region spanning the Hoarusib and Hoanib rivers.
The researchers said due to their adaptation to desert conditions, the reproduction rates of these elephants are abnormally low for African elephants. 
Between January 2002 and November 2009 only 12 calves were born to the population, of which four died within the first year. With the death of two females in the past month, the female breeding population is extremely vulnerable, and subsequently, the desert elephant population in the region too. 
The report, which was published in January 2011, noted that “from a conservation perspective, at the current size and rate of increase it is doubtful that this desert sub-population will soon recover to what it was in the 1960s, prior to extensive poaching”.
The Purros Conservancy in the Kunene Region made headlines earlier this year, when three lionesses were poisoned there by unknown persons. The lionesses were the last remaining members of a unique desert-adapted lion pride. 
That investigation is still ongoing and there are no indications that the ministry or the Police are close to finding out who the perpetrators were or what poison was used.

Who owns America? Hint: It's not China

Truth is elusive.  But it's a good thing we have math.
Our friends at Business Insider know this, and put those two principles to work today in this excellent and highly informative little slideshow, made even more timely by the ongoing talks in Washington, D.C. aimed at staving off a U.S. debt default.
Here's the big idea:
Many people — politicians and pundits alike — prattle on that China and, to a lesser extent Japan, own most of America's $14.3 trillion in government debt.
But there's one little problem with that conventional wisdom: it's just not true. While the Chinese, Japanese and plenty of other foreigners own substantial amounts, it's really Americans who hold most of America's debt.
Here's a quick and fascinating breakdown by total amount held and percentage of total U.S. debt, according to Business Insider:

• Hong Kong: $121.9 billion (0.9 percent)
• Caribbean banking centers: $148.3 (1 percent)
• Taiwan: $153.4 billion (1.1 percent)
• Brazil: $211.4 billion (1.5 percent)
• Oil exporting countries: $229.8 billion (1.6 percent)
• Mutual funds: $300.5 billion (2 percent)
• Commercial banks: $301.8 billion (2.1 percent)
• State, local and federal retirement funds: $320.9 billion (2.2 percent)
• Money market mutual funds: $337.7 billion (2.4 percent)
• United Kingdom: $346.5 billion (2.4 percent)
• Private pension funds: $504.7 billion (3.5 percent)
• State and local governments: $506.1 billion (3.5 percent)
• Japan: $912.4 billion (6.4 percent)
• U.S. households: $959.4 billion (6.6 percent)
• China: $1.16 trillion (8 percent)
• The U.S. Treasury: $1.63 trillion (11.3 percent)
• Social Security trust fund: $2.67 trillion (19 percent)

 

So America owes foreigners about $4.5 trillion in debt. But America owes America $9.8 trillion.
For a smart take on how President Obama and House Republicans should end gridlock over debt and deficits, see our new GlobalPost series The Negotiator, which features Wharton's negotiation guru Stuart Diamond.
And to bone up on China's debt — another potentially big global economic headache — check out this interview with brainy-yet-coherent Northwestern University economist Victor Shih, who spoke with GlobalPost's David Case.

The danger of space debris

In late June, six astronauts living on board the International Space Station (ISS), which orbits some 200 miles above the earth’s surface, received notice that a piece of space debris travelling 29,000 miles per hour would pass dangerously nearby.  NASA officials calculated that the probability of the ISS being hit at around one in 360. (One in 10,000 is NASA’s nominal threshold for which it will authorize a “collision avoidance maneuver.”)
Normally, the ISS receives ample notice so that it can maneuver out of the pathway of potential space debris. However, with less than fifteen hours’ warning, the astronauts were forced to relocate to Soyuz space capsules for only the second time in the ISS’s thirteen-year history.
While the debris missed the space station by 1,100 feet, orbital space debris is a growing threat to civil, military, and commercial satellites in space.
Presently, there are some 22,000 items over ten centimeters across, or roughly the size of a softball, which can be regularly tracked with existing resources and technology. These include the upper stages of launch vehicles, disabled spacecraft, dead batteries, solid rocket motor waste, and refuse from human missions. In addition, there are approximately 300,000 other fragments of space junk measuring between one and ten centimeters, and over 135,000,000 less than one centimeter, which could potentially damage operational spacecraft.
Read: Excessive secrecy in national security.
Though it took forty years to produce the first 10,000 pieces of softball-sized space debris, it required less than a decade for the next 12,000. This recent increase was due in part to two worrying incidents, which, according to NASA, combined to increase the number of total space objects by over 60 percent.  In January 2007, the Chinese military destroyed a defunct polar-orbiting weather satellite with a mobile ballistic missile, and in February 2009 an active Iridium communication satellite and a defunct Russian satellite, which had been predicted to pass each other 1,900 feet apart, unexpectedly collided.
The ability to detect, track, characterize, and predict objects in space and space-related events is known as space situational awareness (SSA). The U.S. Strategic Command’s Joint Space Operations Center (JSpOC) provides this function for the Pentagon by monitoring space debris (over ten centimeters) with a worldwide network of twenty-nine ground-based radars and optical sensors.
In addition to supporting U.S. military and intelligence agencies, JSpOC provides e-mail notifications to commercial space operators when their satellites are at risk from space debris. JSpOC provides twenty to thirty close-approach notifications per day, which last year resulted in satellite owners maneuvering 126 times to avoid collision with other satellites or debris. According to U.S. officials, the United States even notifies the Chinese government when their satellites are threatened by space debris created by the 2007 anti-satellite test. Despite JSpOC’s best efforts, however, these same officials acknowledge that no country has the resources, technical expertise, or geography to meet the growing demands for SSA.
Read: The consequences of stalemate in Libya.
The space debris problem is a classic global governance dilemma: though eleven states can launch satellites, and over sixty countries or government consortia own or operate the approximately 1,100 active satellites, no one country or group of countries has the sovereign authority or responsibility for regulating space. Under Article II of the 1967 Outer Space Treaty: “Outer space, including the moon and other celestial bodies, is not subject to national appropriation by claim of sovereignty.”
The solution to reducing the amount of new space debris, mitigating the threat it poses to satellites and spacecraft, and eventually removing on-orbit debris from space, will require enhanced international cooperation. Last summer, the Obama administration released its National Space Policy, which featured the objective of preserving the space environment via “the continued development and adoption of international and industry standards and policies to minimize debris,” and “fostering the development of space collision warning measures.” Unfortunately, progress toward constructing international agreed upon rules of the road for the responsible uses of space have been slow going.

Particles appear to travel faster than light

 

Scientists in Switzerland say an experiment appears to show that tiny particles traveled faster than the speed of light -- a result that would seem to defy the laws of nature.

The physicists say that neutrinos sent 730 kilometers (453.6 miles) underground between laboratories in Switzerland and Italy arrived a fraction of a second sooner than they should have, according to the speed of light.

The report was published Friday by a group of researchers working on the so-called Opera experiment, based at the European Organization for Nuclear Research (CERN) in Switzerland.

"This result comes as a complete surprise," report author Antonio Ereditato at the University of Bern, in Switzerland, said in a statement.

"After many months of studies and cross checks, we have not found any instrumental effect that could explain the result of the measurement."

The scientists on the Opera project would continue their research, he said, but "are also looking forward to independent measurements to fully assess the nature of this observation."

The finding would seem to challenge Albert Einstein's special theory of relativity, and the long-established law of physics that nothing can exceed the speed of light.

"It is very, very remarkable if it's true," said Professor Neville Harnew, head of particle physics at Oxford University.

"If this proves to be correct, then it will revolutionize physics as we know it."

He will be among scientists from around the world tuning into a webcast seminar held by CERN Friday afternoon, to discuss what Harnew describes as an "ultra-exciting" development that has come "totally out of the blue."

The Opera team's result is based on the observation of more than 15,000 bunches of neutrinos sent between CERN and the Gran Sasso Laboratory in Italy. A neutrino is an electrically neutral subatomic particle, an elemental building block of the universe.

The physicists say the measurements of the distance and the time involved were performed with great precision, to nanosecond accuracy.

And the results seemed to show the neutrinos travel "at a velocity 20 parts per million above the speed of light, nature's cosmic speed limit."

Sergio Bertolucci, research director at CERN, said the Opera team followed good scientific practice by throwing open their findings to other scientists.

"When an experiment finds an apparently unbelievable result and can find no artifact of the measurement to account for it, it's normal procedure to invite broader scrutiny," he said.

"If this measurement is confirmed, it might change our view of physics, but we need to be sure that there are no other, more mundane, explanations. That will require independent measurements."

Ereditato said more research is needed.

"The potential impact on science is too large to draw immediate conclusions or attempt physics interpretations," he said. "My first reaction is that the neutrino is still surprising us with its mysteries."

Harnew said the new finding "cannot currently fit in the standard theories at all" and would have to be confirmed by another experiment -- to ensure there is no subtle systemic error at play -- before a discovery can be claimed.

And he cautions that "neutrino measurements are extremely difficult experiments," making it hard to verify results independently.

Neutrinos, which are emitted during the process of radioactive decay, have only a tiny mass and usually pass through matter without interacting with anything else, making them very hard to detect.

CERN is one of only a handful of laboratories capable of running an experiment like the Opera project, Harnew said. Other possible sites could be J-Parc in Japan, home of the multinational T2K project, and Fermilab in Illinois.

It was only recently discovered that neutrinos, which come in three types, can switch from one type to another. If they can indeed travel faster than mass-less particles, like light, then these mysterious particles will have done even more to turn the world of physics on its head.

AMPICLOX

AMPICLOX 500 (capsules)
AMPICLOX S (syrup)
AMPICLOX 500 I (injection)
AMPICLOX 75 I (neonatal injection)
AMPICLOX D (neonatal drops)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

AMPICLOX 500 (capsules)
AMPICLOX S (syrup)
AMPICLOX 500 I (injection)
AMPICLOX 75 I (neonatal injection)
AMPICLOX D (neonatal drops)

COMPOSITION:
(a) Oral:
Ampicillin trihydrate B.P. and cloxacillin sodium B.P. available as:

AMPICLOX 500	:	Gelatin capsules containing the equivalent of 250 mg ampicillin and 250 mg cloxacillin.
AMPICLOX S	:	Powder for preparing fruit-flavoured suspension. When dispensed as directed each 5 mL of the suspension contains the equivalent of 125 mg ampicillin and 125 mg cloxacillin. The powder contains 0,13% m/m of sodium benzoate B.P. as a preservative.
AMPICLOX D	:	Powder for preparing neonatal drops. When dispensed as directed, each 0,6 mL of the suspension contains the equivalent of 60 mg ampicillin and 30 mg cloxacillin. The powder contains 0,525% m/m sodium benzoate B.P. as a preservative.

(b) Parenteral
Ampicillin sodium B P. and cloxacillin sodium B.P. available as:

AMPICLOX 75 I	:	Sterile powder for preparing the equivalent of 50 mg ampicillin and 25 mg cloxacillin per neonatal vial.
AMPICLOX 500 I	:	Sterile powder for preparing the equivalent of 250 mg ampicillin and 250 mg cloxacillin per vial.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
(a) Bacteriology:
AMPICLOX exhibits in vivo and in vitro bactericidal activity against Gram-positive and Gram-negative organisms.
In vitro sensitivity does not necessarily imply in vivo activity.

(b) Absorption:
Both ampicillin and cloxacillin are acid stable and well absorbed orally, giving peak serum levels about two hours after dosing. As there is a linear dose/response in peak serum level after oral administration of both components, doubling the dose virtually doubles the peak serum levels.

(c) Excretion:
Both components are excreted primarily by the kidneys by glomerular filtration and tubular secretion.
Bile: Bile concentrations of AMPICLOX vary from 3 –48 times the serum concentration, according to the condition of the biliary tract.

(d) Probenecid:
Higher AMPICLOX serum levels can be achieved in patients with normal renal function by the concurrent administration of a renal blocking agent such as probenecid. In adults, a dose of 500 mg of probenecid q.d.s. will result in 1,5 –2 fold increase in AMPICLOX serum levels.

INDICATIONS:
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity resting should, therefore, be carried out wherever possible, to ensure the appropriateness of the therapy.
Infections caused by susceptible organisms where a mixed infection is present and includes penicillin-resistant staphylococci.

CONTRA-INDICATIONS:
Known allergy to penicillin or cephalosporins. Cases of cross sensitivity have been reported.
Babies born of hypersensitive mothers in the neonatal period.
The oral dosage forms are not recommended for chronic, severe, or deep-seated infections such as subacute bacterial endocarditis, meningitis or syphilis. AMPICLOX should not be administered by sub-conjunctival injection or used as an eye drop as it contains cloxacillin.

WARNINGS:
When administered to a patient with penicillin allergy anaphylactic shock may occur. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis. Use with caution in patients with a known history of allergy.
Because of the variability in intestinal absorption of cloxacillin containing products, oral administration is not a suitable substitute for the parenteral route in treatment of severe infections.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for AMPICLOX is 2 –4g per day. In severe infections, dosages may be safely increased.

(i) ORAL:

Adults and children over 10	:	500 mg –1 g (1 –2 x 500 mg capsules) every 6 hours.
Children 2 –10 years	:	250 –500 mg (5 –10 mL of 250 mg/5 mL syrup) every 6 hours.
Children up to 2 years	:	250 mg (5 mL of 250 mg/5 mL syrup) every 6 hours.
Neonates	:	90 mg (0,6 mL i.e. to mark on pipette) every 4 hours.

Note: Best results are obtained if dosages are administered half to one hour prior to meals or at least two hours after meals.

(ii) PARENTERAL

Adults and children over 10	:	500 mg –1 g intravenously or intramuscularly every 4 – 6 hours or as dictated by the severity of the infection.
Children 2 –10 years*	:	Half the adult dose.
Children up to 2 years*	:	Quarter the adult dose.
Neonates*	:	75 mg (i.e. 1 neonatal vial) every 8 hours.

* These dosages should correspond to a daily dosage of 50 –150 mg/kg.
Note: Patients with renal insufficiency may require a reduced dosage.

DIRECTIONS FOR USE:
Intramuscular injection:

500 mg vial	–	add 1,5 mL of Water for Injections B.P. and shake vigorously.
75 mg vial	–	add 0,5 –1,0 mL of Water for Injections B.P. and shake vigorously.

Intravenous injection:
Normally given by slow intravenous injection.

500 mg vial	–	dissolve in 10 mL of Water for Injections B.P. by first dissolving the contents of the vial in approximately 3 mL of the Water for Injections B.P. and then withdrawing the dissolved contents into a 10 mL syringe containing the remaining Water for Injections B.P.
75 mg vial	–	dissolve in 5 mL of Water for Injections B.P.

Intravenous infusion:
Vial contents should be dissolved in a suitable volume of fluid and given as a rapid intravenous infusion over 30 minutes or suitably diluted into the drip tubing. Solutions must be used within 30 minutes of preparation.

Compatibility:
AMPICLOX injectable is compatible with commonly used intravenous fluids including: normal saline, 5% dextrose, dextrose saline, M/6 sodium lactate, Ringer's solution, 1,4% sodium bicarbonate, Dextran 40 injection in normal saline.

Incompatibility:
AMPICLOX should not be added to infusion bottles containing Dextran 40 injection in 5% dextrose, but may be injected into the drip tubing of such an infusion. Cloxacillin has been reported to be incompatible with aminoglycosides, tetracyclines, and other antimicrobial agents including erythromycin and polymyxin B sulphate.
Should not be mixed with blood products or other proteinaceous fluids.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
AMPICLOX may produce diarrhoea, nausea and heartburn. Allergic reactions which may include exfoliative dermatitis, other skin rashes, interstitial nephritis and vasculitis may occur. In this event, withdrawal of AMPICLOX and administration of an antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur. AMPICLOX should be discontinued and the patient treated with the usual agents (adrenalin, corticosteroids or antihistamines).
A generalised sensitivity reaction with urticaria, fever, joint pains and eosinophilia can develop within a few hours to several weeks after starting treatment.
Superinfections by resistant species, such as Pseudomonas or Candida, which do not respond to penicillin therapy may occur.
A sore mouth or tongue and a black hairy tongue have been reported.
Increase in liver enzyme values have been reported.
Care should be taken when high doses are given to patients with renal impairment (because of the risk of neurotoxicity) or congestive heart failure. Renal and haematological systems should be monitored during prolonged and high dose therapy.
Care should be taken when treating patients with syphilis, as the Jarisch-Herxheimer reaction may occur shortly after starting treatment. This reaction, manifesting as fever, chills, headache and reactions at the site of the lesion, can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy.
Haemolytic anaemia and leucopenia, prolongation of bleeding time and detective platelet function have been observed usually following high intravenous doses. Convulsions and other signs of toxicity to the CNS may occur particularly with intravenous administration or in patients with renal failure.
Intrathecal administration of penicillins is not recommended, because it is a potent convulsant when given by this route.
AMPICLOX contains ampicillin and should preferably not be given to patients with infectious mononucleosis, lymphatic leukaemia and patients receiving allopurinol treatment because of an increased risk of developing skin rashes.
AMPICLOX may decrease the efficacy of oestrogen-containing oral contraceptives.
AMPICLOX contains cloxacillin sodium, therefore disturbances of blood electrolytes may follow the administration of large doses.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-Effects and Special Precautions. Treatment is symptomatic and supportive.

IDENTIFICATION:

(a)	AMPICLOX 500	:	Amethyst/black capsules overprinted "AMPICLOX 500".
(b)	AMPICLOX S	:	Free-flowing off-white powder. White suspension.
(c)	AMPICLOX D	:	Free-flowing, off-white powder. White suspension.
(d)	AMPICLOX 75 I	:	White powder. Clear solution.
(e)	AMPICLOX 500 I	:	White powder. Clear solution.

PRESENTATION:

(a)	AMPICLOX 500	:	Glass bottles containing 20 or 100 capsules.
(b)	AMPICLOX S	:	Glass bottles containing powder for reconstitution of 100 mL of suspension.
(c)	AMPICLOX D	:	Glass bottles containing powder for reconstitution of 8 mL of suspension. Each bottle is supplied with a pipette.
(d)	AMPICLOX 75 I	:	Glass vials in packs of 5.
(e)	AMPICLOX 500 I	:	Glass vials in packs of 5.

STORAGE INSTRUCTIONS:
Containers of AMPICLOX 500 should be kept tightly closed in a cool (below 25°C), dry place.
AMPICLOX S, AMPICLOX D, AMPICLOX 75 I and AMPICLOX 500 I preparations should be stored in a cool (below 25°C), dry place.
Once reconstituted AMPICLOX S should be used within 7 days if stored in a cool place (below 25°C) or 14 days if stored in a refrigerator (5°C).
Once reconstituted, AMPICLOX D should be used within 2 days if stored in a cool place (below 25°C) or within 7 days if stored in a refrigerator (5°C).
Once prepared, AMPICLOX 500 I and AMPICLOX 75 I must be used immediately.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

AMPICLOX 500	:	B/20.1.2/57
AMPICLOX S	:	E/20.1.2/6
AMPICLOX 500 I	:	B/20.1.2/45
AMPICLOX 75 I	:	A/20.1.2/616
AMPICLOX D	:	A./20.1.2/612

AMPHOJEL® (suspension)

AMPHOJEL® (suspension)

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

AMPHOJEL^® (suspension)

COMPOSITION:
Each 5 mL contains aluminium hydroxide 300 mg
Preservatives:

Sodium benzoate	0,45% m/v
Benzoic acid	0,05% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.1. (Antacids - Acid Neutralizers)

PHARMACOLOGICAL ACTION:
AMPHOJEL Suspension reacts chemically to neutralize or buffer existing quantities of stomach acids but have no direct effects on its production. The action increases gastric pH, providing symptomatic relief of hyperacidity.
A small amount of aluminium from aluminium hydroxide is absorbed from the intestine.

INDICATIONS:
For the relief of acid indigestion, heartburn, hyperacidity, dyspepsia, gastritis, oesophageal reflux with heartburn, reflux oesophagitis, peptic ulceration.

CONTRA-INDICATIONS:
In patients with symptoms of appendicitis since these medicines may increase the danger of perforation or rupture due to their constipating effects. In patients with hypophosphataemia due to the phosphate binding properties of aluminium salts.
Do not use this product if you are presently taking a prescription antibiotic drug containing any form of tetracycline.
Do not use this product if there is a known history of sensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
Shake well before use.
For the symptomatic relief of hyperacidity states:
Two 5 mL measures, 5 or 6 times a day, between meals and at bedtime, followed by a sip of water if desired, or as directed by a physician.
Do not take more than the recommended dosage in a 24 hour period.
Do not use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a physician.
Paediatric use - Not recommended in infancy. Otherwise in childhood proportional to the adult dosage for a 70 kg adult.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Nausea, vomiting, constipation.
Large doses can cause obstruction.
Excessive doses, or normal doses in patients with low phosphate diets may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia.
Osteomalacia, encephalopathy and dementia have occurred in patients with chronic renal failure on high aluminium-dose as a phosphate-binding agent.
May alter the absorption of other medicines from the gastro-intestinal tract if administered concomitantly. Decreased bowel motility, dehydration or fluid restriction may predispose patients who take antacids containing only aluminium salts to intestinal obstruction.
Special Precautions:
In patients with chronic renal failure, hyperaluminaemia may occur.
Hypophosphataemia may occur with prolonged administration of large doses of aluminium-containing antacids (except aluminium-phosphate) especially in patients with an inadequate dietary uptake of phosphorus.
Laboratory Tests - Serum phosphate levels should be monitored at monthly or bi-monthly intervals in patients on maintenance haemodialysis who are receiving chronic AMPHOJEL therapy.
Interactions - The rate and/or the extent of absorption of many medicines may be altered when they are used concurrently with aluminium hydroxide. Therefore, as a general rule, medication should not be taken within one or two hours of AMPHOJEL, if possible.
Medicines for which the above statement has been shown to apply include: iron, tetracyclines, isoniazid, ethambutol, some anti-muscarinic agents, benzodiazepines, phenothiazines, ranitidine, indomethacin, phenytoin, nitrofurantoin, vitamin A, fluoride and phosphate.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, white suspension, free from any foreign odour or taste.

PRESENTATION:
200 mL and 500 mL glass amber bottles.

STORAGE INSTRUCTIONS:
Keep bottle tightly closed in a cool (below 25°C) place, but keep from freezing.
Protect from direct sunlight.
Keep out of reach of children.

REGISTRATION NUMBER:
E/11.4.1/1229

AMOXYFIZZ

AMOXYFIZZ 125 EFFERVESCENT TABLETS
AMOXYFIZZ 250 EFFERVESCENT TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

AMOXYFIZZ 125 EFFERVESCENT TABLETS
AMOXYFIZZ 250 EFFERVESCENT TABLETS

COMPOSITION:
AMOXYFIZZ 125 –Each effervescent tablet contains amoxycillin trihydrate equivalent to 125 mg amoxycillin.
AMOXYFIZZ 250 –Each effervescent tablet contains amoxycillin trihydrate equivalent to 250 mg amoxycillin.
Each tablet (both strengths) contains 100 mg ASPARTAME (PHENYLALANINE) (a non-nutritive, permitted sweetener)
CONTAINS NO SUGAR.

PHARMACOLOGICAL CLASSIFICATION:
A20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Amoxycillin is a penicillinase-susceptible semi-synthetic aminopenicillin. Amoxycillin exhibits in vitro bactericidal activity against a wide range of Gram-negative and Gram-positive organisms including:

Gram-positive bacteria:
* Staphylococcus aureus (penicillin-sensitive)
Streptococcus pyogenes
* Streptococcus viridans
* Streptococcus faecalis
* Streptococcus pneumoniae
* Corynebacterium species
* Clostridium species
* Bacillus anthracis

Gram-negative bacteria:
Neisseria gonorrhoeae
Neisseria meningitidis
Haemophilus influenzae
(except type b-strains causing meningitis in children).
Bordetella pertussis
* Escherichia coli
Salmonella typhi
Salmonella species
Shigella species
Brucella species
Proteus mirabilis

* Sensitivity tests must be performed.

Note: In vitro sensitivity does not necessarily imply in vivo efficacy.

Amoxycillin is well absorbed orally. After oral administration, there is no significant difference between the peak serum levels in fasting and non-fasting subjects. The presence of food does not interfere with the absorption of amoxycillin. Amoxycillin may, therefore, be taken with meals.
There is insufficient evidence at present to show that amoxycillin penetrates into the cerebro-spinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebro-spinal infections.
Approximately 60% of an oral dose of amoxycillin is excreted unchanged in the active form into the urine within six hours.

INDICATIONS:
Infections caused by susceptible, non-penicillinase-producing organisms including:
Upper respiratory tract infections
Lower respiratory tract infections
Otitis media
Upper urinary tract infections
Lower urinary tract infections
Skin and soft tissue infections
Gonorrhoea
Non-specific urethritis
Typhoid Fever
Gastro-intestinal tract infections

CONTRA-INDICATIONS:
Allergy to penicillins or any of the cephalosporins. Patients with infectious mononucleosis, since they are especially susceptible to amoxycillin-induced skin rashes; patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may also be at increased risk of developing skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for amoxycillin is 750 mg to 1,5 gram per day.

a) GENERAL DOSAGES:
Adults: 250 mg three times a day.
viz.: 1 x 250 mg tablet or 2 x 125 mg tablets in about 100 mL of water (half a glass) three times a day.

Children 1 to 10 Yrs: 125 mg three times a day
viz.: 1 x 125 mg tablet in about 30 mL to 100 mL (about a quarter to half a glass) of water three times a day.

NOTE: In order to ensure that the patient consumes the correct amount of amoxycillin at each dosage, use that minimum amount of water which the patient is able to drink at one time. The tablet will effervesce in the water and a foam layer will be formed on the surface. Allow the tablet to dissolve completely (approximately 5 - 10 minutes) and disperse the foam by swirling or stirring before drinking.

b) SPECIFIC DOSAGES:

Indications	Daily Dosages Adults	Daily Dosages Children	Duration
Gastro-intestinal tract infections	1 - 2 g		4 - 5 days
Acute Typhoid Fever	4 g	-	14 days
	-	100 mg/kg	21 days
Gonorrhoea	2 - 3 g	-	stat

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances, including diarrhoea, nausea and vomiting occur frequently. Allergic reactions may occur, presenting as a pruritic skin rash, an erythematous skin reaction or urticaria. In this event withdrawal of amoxycillin is necessary.
Should a serious anaphylactic reaction occur, amoxycillin should be discontinued and the patient treated with adrenalin, corticosteroids and antihistamines.
Treatment with amoxycillin may give rise to a macupapular rash during therapy or within a few days after completion thereof. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
Pseudomembranous colitis has been reported. Super-infections with non-susceptible organisms may occur. Caution must be exercised in treating patients with dehydration or oliguria because of the possibility of crystalluria.
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity testing should. therefore, be carried out whenever possible, to ensure the appropriateness of the therapy.

Special Precautions:
The dose should be reduced in patients with renal failure. Caution is needed when administering amoxycillin to patients with syphillis, as the Jarisch-Herxheimer reaction may occur in these patients. Amoxycillin may decrease the efficacy of oestrogen-containing oral contraceptives. Due to amoxycillin's effect on the intestinal flora, the absorption of other medicines may be affected.

PHENYLKETONURICS - CONTAINS PHENYLALANINE

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions”.
Treatment is symptomatic and supportive.

IDENTIFICATION:
AMOXYFIZZ 125 - Coin shaped tablets (round with flat surfaces) of pinkish colour
AMOXYFIZZ 250 - Coin shaped tablets (round with flat surfaces) of greenish colour

PRESENTATION:
AMOXYFIZZ 125 - Canisters of 15 tablets in foil wrap.
AMOXYFIZZ 250 - Canisters of 15 tablets in foil wrap.

STORAGE INSTRUCTION:
Store below 25°C in dry place.
Due to the effervescent nature of the tablets, protect against undue exposure to moisture during use by re-wrapping the tablets in the foil and replacing the lid and desiccant each time.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
AMOXYFIZZ 125 TABLETS - 27/20.1.2/382
AMOXYFIZZ 250 TABLETS - 27/20.1.2/383

AMOXIL

AMOXIL 250 (capsules)
AMOXIL 500 (capsules)
AMOXIL S (syrup)
AMOXIL SF (syrup)
AMOXIL D (paediatric drops)
AMOXIL 250 I (injection)
AMOXIL 500 I (injection)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

AMOXIL 250 (capsules)
AMOXIL 500 (capsules)
AMOXIL S (syrup)
AMOXIL SF (syrup)
AMOXIL D (paediatric drops)
AMOXIL 250 I (injection)
AMOXIL 500 I (injection)

COMPOSITION:

(a)	Oral		Amoxycillin trihydrate B.P. available as:
	Amoxil 250	––	Gelatin capsules containing the equivalent of 250 mg amoxycillin.
	Amoxil 500	––	Gelatin capsules containing the equivalent of 500 mg amoxycillin.
	Amoxil S	––	Powder for preparing a fruit flavoured syrup. When reconstituted as directed, each 5 mL of the suspension contains the equivalent of 125 mg amoxycillin. The powder contains 0,295% m/m sodium benzoate B.P. as a preservative.
	Amoxil SF	––	Powder for preparing a fruit-flavoured syrup. When reconstituted as directed, each 5 mL of the suspension contains the equivalent of 250 mg amoxycillin. The powder contains 0,295% m/m sodium benzoate B.P. as a preservative.
	Amoxil D	––	Powder for preparing a fruit flavoured suspension of paediatric drops. When dispensed as directed each 1,25 mL of the suspension, as measured by the pipette provided, contains the equivalent of 125 mg amoxycillin. The powder contains 0,27 % m/m sodium benzoate B.P. as a preservative.
(b)	Parenteral	––	Amoxycillin sodium available as:
	Amoxil 250 I	––	Sterile powder for preparing the equivalent of 250 mg amoxycillin.
	Amoxil 500 I	––	Sterile powder for preparing the equivalent of 500 mg amoxycillin.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
(a)        Bacteriology:

		(i)        Spectrum
			Amoxycillin is a penicillinase-susceptible penicillin. Amoxycillin exhibits in vitro, bactericidal activity against a wide range of Gram-negative and Gram-positive organisms including:

Gram-positive bacteria	Gram-negative bacteria
Staphylococcus aureus (penicillin*-sensitive)	Neisseria gonorrhoea*
Streptococcus pyogenes	Neisseria meningitidis
Streptococcus viridans*	Haemophilus influenzae**
Streptococcus faecalis	Bordetella pertussis
Diplococcus pneumoniae*	Escherichia coli*
Corynebacterium species*	Salmonella typhi
Clostridium species*	Salmonella species
Bacillus anthracis*	Shigella species
	Proteus mirabilis
	Brucella species

*         Sensitivity tests must be performed,
**        except type b-strains causing meningitis in children.

		(ii)        Bactericidal Action
			Amoxycillin exerts a rapid bactericidal activity at normal dosage levels against all susceptible organisms.

(b)        Absorption

	Amoxycillin is extremely well absorbed orally. A single 250 mg oral dose achieves an average peak serum level virtually equal to that achieved by IM injection viz. 5,3 µg/mL oral and 5,6 µg/mL IM. The peak serum level is achieved within 1,5 ––2 hours after oral and 15 minutes after IM or IV administration.
	After oral administration, there is no significant difference between the peak serum levels in fasting and non-fasting subjects. The presence of food does not interfere with the absorption of Amoxil. Amoxil may, therefore, be taken with meals.
	There is a linear/dose response in peak serum levels after both oral and parenteral administration.

(c)        Distribution

	(i)	Sputum: The concentration of amoxycillin in sputum does not decrease as occurs with ampicillin as purulence subsides.
	(ii)	Bile: Amoxil is present in bile obtained from a common bile duct drain of a healthy gall-bladder, however, biliary levels are lower when the gall-bladder is diseased and absent in the presence of biliary tract obstruction.
	(iii)	Urine: the average concentration of Amoxil in urine collected during the first six hours after 250 mg oral dose, is 580 mg/mL.

(d)        Excretion

	(i)	Renal: Approximately 60% of an oral dose of Amoxycillin is excreted unchanged in the active form into the urine within six hours. Approximately 70% - 80% of an intramuscular dose and 90% of an intravenous dose is excreted unchanged in the active form, into the urine within 12 hours.
	(ii)	Biliary: A variable percentage of Amoxil is excreted into the bile.

(e)        Probenecid

Even higher Amoxil serum levels may be achieved after oral administration to patients with normal renal function, by the simultaneous administration of a renal blocking agent such as probenecid. Probenecid should not be given in the presence of abnormal renal function. No data on the effect of probenecid on parenteral Amoxil are yet available.

INDICATIONS:
Infections caused by susceptible, non-penicillinase-producing organisms including:

Upper respiratory tract infections	Lower respiratory tract infections
Otitis media	Typhoid Fever
Upper urinary tract infections	Lower urinary tract infections
Skin and soft tissue infections	Gastro-intestinal tract infections
Gonorrhoea	Non-specific urethritis

CONTRA-INDICATIONS:
Allergy to penicillins or any of the cephalosporins is an absolute contra-indication to the use of Amoxil.

WARNINGS:
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. Before commencing therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergies.
If an allergic reaction occurs, appropriate therapy should be instituted and amoxycillin therapy discontinued.
There is insufficient evidence at present to show that Amoxil penetrates into the cerebro-spinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebro-spinal infections.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for Amoxil is 750 mg ––1,5 g/day, but in serious infections up to 6 g daily has been administered.

(a)	General dosages:
	(i)	Oral
		Adults: 250 mg ( 1 x 250 mg capsule or 5 mL of 250 mg/5 mL syrup) three times a day.
		*Children 2 ––10 years: 125 mg (5 mL of 125 mg/5 mL syrup) three times a day.
		*Children 6 months ––2 years: 125 mg (one full pipette of paediatric suspension or 5 mL of 125 mg/5 mL syrup) three times a day.
		*Infants 0 ––6 months: 62,5 mg (half pipette measure of paediatric suspension) three times a day.
		*Premature infants 1,0 ––2,5 kg: 30,0 ––62,5 mg (quarter to half pipette measure of paediatric suspension) once daily for the first 1 ––2 weeks depending on the size and maturity of the infant, thereafter dose may be given 2 ––3 times daily.
		In severe infections these dosages may be increased.
	(ii)	Parenteral
		Adults: Mild to moderate infections: 250 mg ––500 mg IV or IM three times a day.
		Severe infections: 500 mg ––2 g IV 4 ––6 times a day.
		In particularly severe infections doses of up to 3 g may be administered by rapid intravenous infusion over a period of 30 minutes. This may be repeated every four hours.
		Children 2 ––10 years: Half the adult dose. *
		Children up to 2 years: Quarter the adult dose. *
		* This should correspond to a daily dosage of 35 ––100 mg/kg.

NOTE:

(1)	Patients with renal insufficiency may possibly require a reduced dose.
(2)	During treatment with high doses of Amoxil particularly by bolus injection an adequate fluid intake and urinary output must be maintained. Indwelling catheters should be checked regularly for potency since at room temperature high urinary concentration of Amoxil may precipitate out of solution.

DIRECTIONS FOR PARENTERAL USE:
On dissolution of the powder, a transient colour change (red to purple) may be seen before a clear solution is obtained. The more concentrated IM solutions will be a pale yellow colour and may show slight opalescence.

Intramuscular injections:
Amoxil by intramuscular injection is always painful. If deemed necessary, the transient pain can be reduced by the use of 0,5% procaine solution as a diluent.
250 mg vial ––add 1,5 mL Water for Injections B.P. and shake vigorously.
500 mg vial ––add 2,5 mL Water for infections B.P. and shake vigorously.

Intravenous Injections:
Normally given as a bolus injection every 30 seconds (half a minute).
250 mg vial ––dissolve in 10 mL Water for Injections B.P.
500 mg vial ––dissolve in 10 mL Water for Injections B.P.

Intravenous Infusion:
3 g should be dissolved in 50 mL Water for Injections B.P. and given as a rapid intravenous infusion over 30 minutes (half an hour).
Solutions must be used within half an hour after preparation.
When reconstituted at the recommended dilutions, sodium amoxycillin is stable in most commonly used infusion fluids at ambient temperature. It is relatively less stable in solutions containing sugars.

Compatibility:
Amoxil injections are compatible with commonly used intravenous fluids including: sodium chloride, Ringer's solution, sodium lactate, compound lactate, 5% dextrose and sodium chloride plus 4% dextrose.
Intramuscular Injection of Amoxil is compatible with 0,5% procaine solution and with a 1% lignocaine solution.

Incompatibility:
Amoxil should not be added to infusion bottles containing proteinaceous fluids such as protein hydrolysates, intravenous lipid emulsions, blood or plasma.

Specific dosages: (oral or parenteral)

Indications	Daily Dosages*			Duration
	Adults	Children
Gastro-intestinal tract infections	1 ––2 g	––	4 ––5 days
Acute Typhoid Fever	4 g	––	14 days
	––	100 mg/kg	21 days
Gonorrhoea	2 ––3 g	––	Stat

* Either oral or parenteral administration.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Precautions:
Allergic reactions presenting as a skin rash, pruritus and urticaria have been reported less frequently. Other reactions including angio-oedema, anaphylaxis, erythema multiforma, Stevens-Johnson syndrome and exfoliative dermatitis may occur in exceptional cases. If a skin rash occurs, treatment should be discontinued. In the event of an anaphylactic reaction, immediate treatment with adrenalin, oxygen, corticosteroids and antihistamines should be initiated.

Blood:
Blood dyscrasias have been reported less frequently. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Liver:
A moderate rise in SGOT and for SGPT has been reported in exceptional cases.
At high doses of parenteral Amoxil, caution must be exercised in treating patients with dehydration or oliguria because of the possibility of cristalluria.
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity testing should, therefore be carried out wherever possible, to ensure the appropriateness of the therapy.
Gastro-intestinal disturbance including diarrhoea, nausea and vomiting have been reported. Pseudo-membranous colitis has been reported, if this condition occurs, treatment should be discontinued and appropriate therapy, e.g. vancomycin, should be initiated.
The dose should be reduced in patients with renal failure. Periodic assessment of renal, hepatic, and haematopoietic function should be made during prolonged therapy. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms
Amoxycillin should preferably not be used in patients with infectious mononucleosis and should also be used with caution in patients glandular fever, lymphatic leukaemia, and patients treated with allopurinol since they are especially susceptible to ampicillin-induced skin rashes.
Due to Amoxycillin's effect on intestinal flora, the absorption of other medicine may be affected. Amoxycillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
The absorption of concurrently administered digoxin may be increased during treatment with Amoxycillin.
Caution is needed when administering Amoxycillin to patients with syphilis, as the Jarisch-Herxheimer reaction may occur in these patients

Pregnancy and Lactation:
Animal reproduction studies have failed to demonstrate a risk to the foetus. There are no adequate and well controlled studies in pregnant women.
Amoxil is excreted in breast milk, and should be used with caution when administered to lactating women.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
If encountered, gastro-intestinal symptoms and disturbance of the fluid and electrolyte balance may be evident. They may be treated symptomatically and supportive with attention to the water/electrolyte balance. In the absence of an adequate fluid intake and urinary output, crystalluria is a possibility and the antibiotic may be removed from the circulation by haemodialysis.
Oral administration can cause gastro-intestinal symptoms such as transient diarrhoea, nausea and colic which are dose related and a result of local irritation not toxicity.

IDENTIFICATION:

Amoxil 250	––	Pink/blue capsules overprinted "Amoxil 250".
Amoxil 500	––	Pink/blue capsules overprinted "Amoxil 500".
Amoxil S	––	Free-flowing, off-white powder. Yellowish suspension.
Amoxil SF	––	Free-flowing, off-white powder. Yellowish suspension.
Amoxil D	––	Free-flowing, off-white powder. Yellowish suspension.
Amoxil 250 I	––	White powder. Clear solution.
Amoxil 500 I	––	White powder. Clear solution.

N.B. Amoxil 250 I and Amoxil 500 I: On dissolution of the powder a transient colour change (red to purple) may be seen before a clear solution is obtained. The more concentrated IM solutions are pale yellow and opalescent.

PRESENTATION:

Amoxil 250	––	Securitainers containing 15, 100 or 500 x 250 mg amoxycillin capsules.
Amoxil 500	––	Securitainers containing l5 or 100 x 500 mg amoxycillin capsules.
Amoxil S	––	Bottles containing powder for reconstitution to 100 mL of 125 mg/5 mL syrup.
Amoxil SF	––	Bottles containing powder for reconstitution to 100 mL of 250 mg/5 mL syrup.
Amoxil D	––	Bottles containing powder for reconstitution to 20 mL of suspension of paediatric drops. Each bottle is supplied with a pipette.
Amoxil 250 I	––	Vials containing sterile powder for the preparation of a single dose 250 mg amoxycillin in packs of 5 vials.
Amoxil 500 I	––	Vials containing sterile powder for the preparation of a single dose of 500 mg amoxycillin in packs of 5 vials.

STORAGE INSTRUCTIONS
Containers of Amoxil 250 and Amoxil 500 should be kept tightly closed in a cool (below 25°C), dry place.
Once dispensed, Amoxil S and Amoxil SF must be used within 14 days and stored in a cool place (below 25°C), preferably in a refrigerator (5°C). Once dispensed, Amoxil D must be used within 14 days and stored in a cool place (below 25°C), preferably in a refrigerator (5°C).
Vials of Amoxil 250 I and Amoxil 500 I are stable for 24 months if stored in a cool (below 25°C), dry place. Once reconstituted, the contents must be used within 30 minutes.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

Amoxil 250	––	E/20.1.2/276
Amoxil 500	––	G/20.1.2/66
Amoxil S	––	E/20.1.2/75
Amoxil SF	––	J/20.1.2/29
Amoxil D	––	E/20.l.2/119
Amoxil 250 I	––	K/20.1.2/38
Amoxil 500 I	––	K/20.1.2/39

AMOXICILLIN HEXAL® 500

AMOXICILLIN HEXAL® 500

MOXCP1

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

Amoxicillin Hexal^® 500 (film coated tablets)

COMPOSITION
Each film coated tablet contains 500 mg Amoxicillin as the trihydrate.

PHARMACOLOGICAL CLASSIFICATION
A 20.1.2 Penicillins

PHARMACOLOGICAL ACTION
Amoxicillin is a semi-synthetic penicillinase susceptible penicillin, inhibiting bacterial cell wall synthesis. It has a broad spectrum of in-vitro bactericidal activity against both gram positive and gram negative organisms. In vitro sensitivity does not necessarily imply in vivo efficacy.
Amoxicillin is acid stable and is rapidly and completely absorbed from the gastro-intestinal tract (75-90%). Peak plasma concentrations of about 5 mcg per mL are achieved 1 to 2 hours after a 250 mg dose. Presence of food does not affect the total absorption of the medicine. Amoxicillin is widely distributed in body tissues and fluids. It crosses the placenta and appears in the breast milk. Distribution into the cerebrospinal fluid is low in subjects with non inflamed meninges. Amoxicillin is about 20% protein bound and has a half life of 1 to 1,5 hours.
Amoxicillin is metabolised to a limited extent and about 60% is excreted in urine in six hours by glomerular filtration and tubular secretion. High concentrations may be reached in bile and some amount may be excreted in the faeces.

INDICATIONS
Amoxicillin Hexal 500 is indicated in the treatment of infections caused by susceptible non penicillinase producing strains :

-	Genitourinary tract infections caused by Escherichia coli, Proteus mirabilis and Enterococcus faecalis.
-	Acute uncomplicated anogenital and urethral gonorrhoea in males and females, caused by Neisseria gonorrhoeae.
-	Infections of the nose, ear and throat caused by Streptococci, Pneumococci, non penicillinase producing Staphylococci and Haemophilus influenzae.

Skin and soft tissue infections caused by Streptococci, non penicillinase producing Staphylococci, E. coli and Proteus mirabilis.
In the therapy of duodenal ulcer associated with Helicobacter pylori, amoxicillin used in conjunction with another appropriate antibiotic and a proton pump inhibitor may be useful.

CONTRA-INDICATIONS
Penicillin hypersensitivity or hypersensitivity to any of the ingredients of this preparation.
A history of allergic reaction to any of the penicillins / cephalosporins.
A history of antibiotic associated colitis.
Infectious mononucleosis.
Patients with lymphatic leukaemia as well as patients suffering from hyperuricaemia, who are being treated with allopurinol, may be at increased risk of developing skin rashes.
Babies, born to hypersensitive mothers, who are still in the neonatal period.

WARNINGS
Before initiating therapy with amoxicillin or any other penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or cephamycins. There is clinical and laboratory evidence of partial cross allergenicity of the penicillins and cephalosporins.
Care should be taken when treating patients with syphilis as the Jarisch-Herxheimer reaction may occur. This reaction, manifesting as fever, chills, headache and reactions at the site of the lesion, can be dangerous in cardiovascular syphilis or where there is a risk of increased local damage as with optic atrophy.
Patients with a history of gastro-intestinal disease, especially antibiotic associated colitis should be treated with amoxicillin with caution since penicillins may cause pseudomembranous colitis.

DOSAGE AND DIRECTIONS FOR USE
Adults:
The average adult dose is 750 mg to 1,5g per day.
ie a half to one Amoxicillin Hexal 500 tablet every 8 hours.
Higher doses have been administered in severe infections.

For Gonorrhoea
Adults - 3g as a single dose together with probenecid 1g
Children over 2 years - 50 mg/kg amoxicillin with 25 mg/kg probenecid as a single dose.

In the treatment of beta haemolytic streptococcal infections a therapeutic dose must be administered for at least 10 days.

Eradication of H. pylori : to decrease the recurrence of duodenal ulcer in combination with a proton pump inhibitor and another antibiotic:
Amoxicillin 1000 mg twice daily in combination with clarithromycin 500 mg twice daily and omeprazole 20 mg daily for 7 to 10 days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Skin rashes are the most common side effects and vary from maculopapular to urticarial.
Urticarial reactions are typical of penicillin hypersensitivity reactions.
If serious anaphylactic reaction occurs, Amoxicillin Hexal 500 should be discontinued and the patient treated with adrenalin, corticosteriods and antihistamines.
Most patients with infectious mononucleosis develop a maculopapular rash, and patients with other lymphoid disorders seem to be more at risk. Avoid using Amoxicillin Hexal 500 in these instances.
Gastro-intestinal side effects including diahrroea, nausea and vomiting may occur quite frequently.
Pseudomembranous colitis has also been reported.
Super-infection is relatively common.
Doses should be reduced in severe renal failure.
Use in pregnancy : animal reproduction studies have failed to demonstrate a risk to the foetus. However, there are no adequate and well controlled studies in pregnant women.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See “Side-effects and Special Precautions”. Should a serious allergic reaction occur the medicine should be discontinued.
Treatment is supportive and symptomatic.

IDENTIFICATION
Amoxicillin Hexal 500 - white, round, biconvex, film coated tablets, with a score notch.
13,1-13,2mm (d) X 5,0-5,4mm (h)

PRESENTATION
Amoxicillin Hexal 500 –Opaque white securitainers containing 100 tablets

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN
Do not remove the tablets from the container until required for use.

REGISTRATION NUMBER
Amoxicillin Hexal 500 –32/20.1.2.0091

AMOXICAP 250 (CAPSULE)

AMOXICAP 250 (CAPSULE)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

AMOXICAP 250 (CAPSULE)

COMPOSITION:
Each capsule contains:
Amoxycillin Trihydrate equivalent to Amoxycillin 250 mg

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
Amoxycillin is a semisynthetic beta-lactamase-susceptible penicillin, which has in vitro bactericidal activity against broad spectrum of non beta-lactamase producing Gram positive, and Gram negative organisms. The spectrum of activity does not include those organisms that produce beta lactamases, namely resistant staphylococci, and all strains of Pseudomonas, Klebsiella and Enterobacter.
The following organisms are generally sensitive to the bactericidal action of amoxycillin in vitro. In vitro sensitivity does not mean in vivo efficacy
[(*) denotes sensitivity tests must be performed]
Gram positive bacteria
Staphylococcus aureus (penicillin sensitive)*
Streptococcus pyogenes
Streptococcus viridans*
Streptococcus faecalis*
Streptococcus pneumoniae*
Corynebacterium species*
Clostridium species*
Bacillus anthracis*
Listeria monocytogenes
Gram negative bacteria
Neisseria meningitides* (except the carrier state)
Neisseria gonorrhoeae*
Haemophilus influenza*
Bordetella pertussis
Escherichia coli*
Salmonella species*
Shigella species*
Proteus mirabilis*
Pasteurella multocida*
Fusabacterium species*
Helicobacter pylori
Leptospira species

PHARMACOKINETICS:
Absorption:
Amoxycillin is stable in the presence of acidic gastric secretions. Peak blood levels are achieved 1-2 hr after administration. There is a linear dose response in peak serum levels.
Food does not interfere with the absorption of amoxycillin.
Distribution:
Approximately 18% of the total plasma amoxycillin content is protein bound. Amoxycillin diffuses readily into most body tissues with the exception of the brain and spinal fluid. Inflammation generally increases the permeability of the meninges to penicillins and this may apply to amoxycillin.
Excretion:
The elimination half-life is approximately 1 hour. Amoxycillin is primarily excreted via the kidneys.
Small amounts of the drug are also excreted in the faeces and bile.
Amoxycillin crosses the placenta and is distributed into breast milk.

INDICATIONS:
Amoxicap 250 formulations are indicated for the treatment of mild to moderately severe infections caused by susceptible organisms:

1.	Upper Respiratory tract infections such as sinusitis, otitis media, tonsillitis
2.	Lower respiratory tract infections such as bronchitis, lobar and bronchopneumonia
3.	Gastro-intestinal infections such as typhoid fever
4.	Other infections including Borreliosis (Lyme disease)
5.	In the following infections, amoxycillin therapy should be initiated only if there is microbiological evidence that the causative organism is sensitive to amoxycillin:
	Skin and soft tissue infections
	Urinary tract infections: cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy
6.	“As part of combination therapy in established Helicobacter pylori infection, associated with duodenal ulceration.”
7.	Prophylaxis of endocarditis

CONTRA-INDICATIONS:
Hypersensitivity to penicillins or to cephalosporins. Cross-sensitivity between penicillins and cephalosporins is well documented.

WARNINGS:
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Before initiating therapy with Amoxicap 250, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity, who have experienced severe reactions when treated with cephalosporins.
If an allergic reaction occurs, Amoxicap 250 should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions may require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation may also be required.
Amoxicap 250 should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxycillin.
Prolonged use may result in overgrowth of non-susceptible organisms. Pseudomembranous enterocolitis has been reported.
Prolongation of prothrombin time has been reported rarely in patients receiving Amoxicap 250. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
Periodic assessment of organ function, including renal, hepatic and haematopoietic functions, is advisable during prolonged therapy.
Transient hepatitis and cholestatic jaundice has been reported. Amoxicap 250 should be used with caution in patients with evidence of hepatic dysfunction.

INTERACTIONS:
Probenecid decreases the renal tubular secretion of Amoxicap 250. Concurrent use with Amoxicap 250 may result in increased and prolonged blood concentrations of Amoxicap 250.
Amoxicap 250 may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
The concomitant administration of allopurinol and ampicillin substantially increases the incidence of skin rashes in patients receiving both agents as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients.
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of Amoxicap.
Interaction with Laboratory tests:
It is recommended that when testing for the presence of glucose in urine during Amoxicap 250 treatment, enzymatic glucose oxidation methods should be used. Due to the high urinary concentrations of Amoxicap 250, false positive readings are common with chemical methods.

PREGNANCY AND LACTATION:
Use in pregnancy:
The safety of Amoxicap 250 in pregnancy has not been established.
Use in lactation:
Amoxicap 250 is distributed into breast milk. Although significant problems in humans have not been documented, the use of Amoxicap 250 by nursing mothers may lead to sensitisation, diarrhoea, candidiasis and skin rash in the infant.

DOSAGE AND DIRECTIONS FOR USE:
The total daily dose as below is administrated in divided doses. The most common regimen is 8 hourly.

ORAL ADMINISTRATION:
Treatment should be continued for 48 to 72 hours beyond the time that a clinical response has been obtained. It is recommended that at least 10 days treatment be given for any infection caused by beta-haemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.
The absorption of Amoxicap 250 is not affected significantly when taken with food.
Adults and children over 40 kg:
Total daily dosage of 750 mg to 3 g administered in divided doses
Maximum recommended dose: 6 g/day in divided doses
Respiratory tract infections: 500 mg administered 8 hourly.
Lyme disease: 4 g/day in isolated erythema chrionicum migrans and 6 g/day in the case of generalised manifestations, both for a minimum of 12 days.
Gonorrhoea: 3 g with 1 g probenecid
Eradication of Helicobacter pylori: 750 mg - 1 g in combination treatment given 12 hourly for the eradication of established H pylori infection associated with duodenal ulceration for seven days.

Children under 40 kg:
20 –50 mg/kg/day in divided doses
Maximum recommended dose: 150 mg/kg/day in divided doses
Lyme disease: 25 –50 mg/kg/day in isolated erythema chrionicum migrans and 100 mg/kg/day in the case of generalised manifestations, both for a minimum of 12 days

Elderly:
No adjustments needed: as for adults unless there is evidence of severe renal impairment (see below)

Renal Impairment:

Glomerular filtration rate	> 30 mL/min:	No adjustment needed
Glomerular filtration rate	10-30 mL /min:	Maximum 500 mg 12 hourly
Glomerular filtration rate	< 10 mL/min:	Maximum 500 mg daily

In patients receiving peritoneal dialysis: Maximum 500 mg daily

PROPHYLAXIS OF ENDOCARDITIS:
Prophylaxis with alternative antibiotics should be considered if the patient has received penicillin within the previous month or is allergic to penicillin.
For dental, oral or upper respiratory tract procedures:
Prophylaxis for patients undergoing dental extraction, scaling or surgery involving gingival tissues, tonsillectomy, adenoidectomy, bronchoscopy with a rigid bronchoscope and surgical procedures that involve respiratory mucosa.
For patients NOT having a general anaesthetic:
Adults: 2 g orally, 1 hour before the procedure
Children: 50 mg/kg, 1 hour before the procedure
Children’s dose not to exceed the adult dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most frequently reported adverse effects are diarrhoea, nausea, vomiting, indigestion, abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes.
The following adverse reactions have been reported and may occur with Amoxicap 250.
Hypersensitivity reactions:
Skin rashes, pruritus and urticaria, serum sickness-like syndrome, erythema multiforme, rare cases of Stevens-Johnson syndrome, hypersensitivity vasculitis and less frequently bullous exfoliative dermatitis and toxic epidermal necrolysis have been reported. Whenever such reactions occur, Amoxicap 250 should be discontinued. Serious and occasional fatal hypersentivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillin (see Warnings).
Interstitial nephritis can occur rarely.
Gastrointestinal reactions:
Nausea, vomiting, diarrhoea, gastritis, stomatitis, glossitis, black ‘hairy’ tongue, enterocolitis, mucocutaneous candidiasis and antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis). If gastro-intestinal reactions are evident, they may be reduced by taking Amoxicap 250 at the start of a meal.
Hepatic effects:
Hepatitis and cholestatic jaundice have been reported. The events may be severe, and occur predominantly in adult or elderly patients. Signs and symptoms usually occur during or shortly after treatment, but in some cases may not become apparent until several weeks after treatment has ceased. The hepatic effects are usually reversible. However, in extremely rare circumstances, death has been reported. These have almost always been cases associated with serious underlying disease or concomitant medication.
A moderate raise in Aspartate transaminase (AST) and/or Alanine transaminase (ALT) has been noted in patients treated with Amoxicap 250, but the significance of these findings is unknown.
Renal effects:
Crystalluria has been reported.
Haematological effects:
Haemolytic anaemia, reversible thrombocytopenia, thrombocytopenic purpura, eosinophilia, reversible leucopoenia and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of the patients treated with Amoxicap 250. Prolongation of bleeding time and prothrombin time have been reported less frequently. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly.
Nervous System:
CNS effects have been seen rarely. These include reversible hyperactivity, dizziness, headache and convulsions. Convulsions may occur with impaired renal function or in those receiving high doses.
Miscellaneous:
Superficial tooth discolouration has been reported especially with the suspension and chewable tablet formulations. It can usually be removed by brushing.
SPECIAL PRECAUTIONS:
Caution is needed when administering amoxycillin to patients with syphilis, as the Jarisch-Herxheimer reaction may occur in these patients.
When high doses are administered, adequate fluid intake and urinary output must be maintained.
The sodium content must be taken into account in patients on a sodium-restricted diet if the administration of high doses is necessary.
Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function, is advisable during prolonged therapy. Since Amoxicap 250 contains amoxycillin, an aminopenicillin, it is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxycillin is used. Amoxicap 250 should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to amoxycillin induced skin rashes.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, the agent should be discontinued and/or appropriate therapy instituted.
Impaired hepatic function:
Changes in liver function tests have been observed in some patients receiving Amoxicap 250. It should be used with care in patients with evidence of severe hepatic dysfunction.
Impaired renal function:
In patients with moderate or severe renal impairment Amoxicap 250 dosage should be adjusted. (See Dosage and Directions for use).
Use in lactation:
Amoxycillin is excreted in the milk. Therefore, caution should be exercised when Amoxicap 250 is administered to a nursing woman.
The use of Amoxicap 250 may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage with Amoxicap 250 is usually asymptomatic. However, gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water and electrolyte imbalance should be treated symptomatically.
Adequate fluid intake and urinary output must be maintained to minimise the possibility of crystalluria.
Amoxicap 250 may be removed from the circulation by haemodialysis.

IDENTIFICATION:
A scarlet and grey capsule with “AX250”on one end and “HD”on the other end printed in black ink.

PRESENTATION:
PVC Blister strips of 10 capsules in a pack of 100 in a unit carton.
Opaque plastic bottles containing 100, 500 and 1000 capsules

STORAGE INSTRUCTIONS:
Store below 25ºC. Protect from light. Do not remove the blisters from the carton until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER (OR REFERENCE NUMBER):
37/20.1.2/0446