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Amonex

Vixa Pharmaceutical Co. Ltd
13B, Sunny Jigide Street, Off Celestial Way, Ogudu, Lagos; 57, Isheri Rd, Aguda, Ogba, Ikeja, Lagos.
Email: vixapharmacustomer@gmail.com; info@vixagroup.com
Tel: 234-1-815-065-1200; 234-1-815-065-1199; 815-506-1205

Brand Name

Amonex

Manufacturer

Therapeutic Class

Antibacterial, Penicillins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN: 04-6323): Each capsule contains Amoxicillin trihydrate equiv. to 250 or 500 mg Amoxicillin.

Pack size: Folding boxes with 10 blisters containing 10 capsules with 250 or 500 mg base each. Clinic packs in plastic jars containing 1000 capsules with 250 or 500 mg base each.

 AMONEX 250  AMONEX 500

Syrup (NRN: ): Each 5 ml syrup contain Amoxicillin trihydrate equiv. to 125 or 250 mg Amoxicillin.

Pack size: Single folding boxes with bottles containing after reconstitution 60 or 100 ml of syrup.

 

Injection (NRN: ): Each vial contains Amoxicillin trihydrate equiv. to 1000 mg Amoxicillin.

Pack size: Folding boxes with 10, 25 or 50 vials containing 250, 500, 1000 mg base each.

Pharmacology

Amoxicillin is aminopenicillin with actions and uses very similar to those of ampicillin. Absorption from the gastrointestinal tract is better than for ampicillin and is less affected by food. Adverse effects are similar although the incidence of diarrhoea may be less with amoxicillin.

Indications

Treatment of infections caused by penicillin-sensitive gram positive bacteria as well as H. influenzae, E. coli, P. mirabilis, Salmonella, and some Shigellosis species. Treatment of bronchitis, otitis media, bacterial pharyngitis, bacterial pneumonia, sinusitis, urinary tract infections.

Contra-indications

Known history of hypersensitivity or allergic reactions to any of the penicillins.

Precautions/Warnings

Patients allergic to one penicillin may be allergic to other penicillins also. Penicillins are distributed into breast milk. Although significant problems have not been documented, the use of penicillins in nursing mothers may lead to sensitisation, diarrhoea, candidiasis and skin rash in the infant.

Interactions

Adverse Effects

More frequent (more than 10%); gastrointestinal reactions (mild diarrhoea, nausea or vomiting), headache, oral candidiasis, vaginal candidiasis.

Occasional (1-3-3%): Allergic reactions (anaphylaxis), exfoliative dermatitis, serum sickness like reactions, skin rash, hives, itching.

Rare (0.001-1%): Clostridum difficile colitis (may occur up to several weeks after discontinuation of the medication), interstitial nephritis, leukopenia, neutropenia, pain at the site of injection, or thrombocytopenia, seizures (in patients receiving high doses and/or having a renal function impairment.

Dosage & Administration

Capsules: 250 to 500 mg every six hours. The usual adult prescribing limits are 4, 5g a day.

Injections:

Intramuscular or intravenous 250 to 500 mg every six hours, bacterial endocarditis, meningitis or septicaemia 1 to 2 g every 3 to 4 hours; listeriosis 50 mg per kg of body weight every 6 hours.

Neonates up to 2 kg: 25 to 50 mg per kg of body weight every 12 hours during the first week of life, thereafter 50 mg every eight hours.

Neonates over 2 kg: 50 mg per kg of body weight every 8 hours during the first week of life; thereafter every six hours.

Infants up to 20 kg: 12.5 mg per kg of body weight every 6 hours.

Infants over 20 kg should receive the usual adult dose.

Syrups:

Infants up to 6 kg: 25 to 50 mg every eight hours.

Infants 6 to 8 kg: 50 to 100 mg every eight hours.

Infants and children up to 20 kg: 16.7 to 33 mg per kg body weight every eight hours.

Adults 250 to 500 mg every eight hours.

Overdosage:

There is no specific antidote for ampicillin. Treatment is primarily symptomatic and supportive. Decrease absorption (induction of emesis or gastric lavage, multiple doses of charcoal), enhance elimination (dialysis is indicated to aid the removal of penicillins from the blood), monitor and give supportive care.

Storage/Handling Recommendations

Review Date

2016-06-24 08:19:24