Moxypen 250 mg/500 mg/125 mg/5 ml Capsules
Clinical Summary
Quick overview from the medicine insert
Indication
Infections caused by susceptible, non-penicillinase-producing organisms.
Dosage (summary)
Adults: 250 mg three times daily; 500 mg for severe infections. Children: 125 mg three times daily.
Onset of Action / Duration
Onset: 2 hours, Duration: Not specified
Special Populations
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Use with caution; safety not established.
Key Drug Interactions
- Decreases efficacy of oestrogen-containing oral contraceptives
Contraindications
- Known sensitivity to penicillins or cephalosporins
- Infectious mononucleosis
Common side effects
- Allergic reactions
- Gastrointestinal discomfort
- Diarrhoea
- Nausea
- Vomiting
Counselling Points
- Take with or without food
- Complete the full course
- Report any allergic reactions immediately
Serious warnings
- Caution in patients with syphilis due to Jarisch-Herxheimer reaction
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
Infections caused by susceptible, non-penicillinase-producing organisms including:
- Respiratory tract infections (upper and lower): sinusitis, phyrngitis, epiglottitis, acute and chronic bronchitis and acute typical pneumonia.
- Otitis media;
- Urinary tract infections;
- Uncomplicated gonococcal infections;
- Meningitis (sensitivity tests must be performed);
- Gastro intestinal infections including salmonella and typhoid;
- Uncomplicated gastro enteritis and enteric fever;
- Miscellaneous: Skin and soft tissue infections, bacteremia and as adjunct in the treatment of sepsis caused by gram-negative bacteria.
4.2 Posology and method of administration
Adults and children over 12 years: 250 mg of amoxycillin three times a day; 500 mg of amoxycillin may be required in some severe infections. In gonorrhea the usual dose is the equivalent of 3 g given as a single dose, usually combined with 1 g probenecid.
To reconstitute:
- 100 ml suspension: Add 59 ml water, invert bottle and shake well until all the powder is dissolved.
- 75 ml suspension: Add 44,25 ml water, invert bottle and shake well until all the powder is dissolved. (Hospital pack).
Children: The normal dose for children 6 months to 10 years of age is equivalent of 125 mg (i.e. 5 ml of 125 mg/5 ml) three times a day. 0 u2013 6 months: 62,5 mg three times a day.
4.3 Contraindications
Patients known to be sensitive to penicillins or cephalosporins. Should not be given to 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 be at increased risk of developing skin rashes.
4.4 Special warnings and precautions for use
MOXYPEN should be used with caution in patients with syphilis, as the Jarisch-Herxheimer reaction may occur.
4.5 Interactions with other medicines
MOXYPEN may decrease the efficacy of oestrogen-containing oral contraceptives. MOXYPEN may affect the absorption of other medicines, due to its effect on the gastro intestinal flora.
4.8 Undesirable effects
Supra-infections with non-susceptible organisms, for example with Candida and Pseudomonas, may occur. Pseudomembranous colitis has been reported. Allergic reactions can occur in persons sensitised to penicillins, presenting with a pruritic skin rash, an erythematous skin reaction or urticaria. Should a serious anaphylactic reaction occur, MOXYPEN should be discontinued and the patient treated with adrenaline, corticosteroids and antihistamines. Gastro intestinal discomfort, diarrhoea, nausea and vomiting may occur. Reduced doses may be required in patients with impaired renal function. Raised serum transaminase concentrations have been reported. Other adverse effects that have been reported include photosensitivity, blood dyscrasias such as neutropenia and pancytopenia and auditory and visual hallucinations.
4.9 Overdose
See u201cSIDE EFFECTSu201d. Treatment is symptomatic and supportive.