Moxypen 250 mg/500 mg/125 mg/5 ml Capsules

    Moxypen 250 mg/500 mg/125 mg/5 ml Capsules

    S4
    PDF Leaflet Revision Date: 19 April 1991

    API: Amoxicillin | Company: Litha Pharma

    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
    Important Disclaimer

    The Moxypen 250 mg/500 mg/125 mg/5 ml Capsules professional information leaflet below is the property of Litha Pharma and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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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.

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