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ARROW ROXITHROMYCIN Coated tablet (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Arrow – Roxithromycin 150, 150 mg, coated tablets. Arrow – Roxithromycin 300, 300 mg, coated tablets.

Qualitative and quantitative composition

Each tablet contains 150 mg or 300 mg of roxithromycin. For the full list of excipients, see section 6.1.

Pharmaceutical form

White, round, coated tablets.

Therapeutic indications

Adults Roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible micro-organisms: upper respiratory tract ...

Posology and method of administration

This product may not be interchangeable with other products containing this ingredient in the New Zealands market. The bioequivalence with Rulide marketed in Australia has been demonstrated. Roxithromycin ...

Contraindications

Arrow Roxithromycin is contraindicated in the following conditions: known hypersensitivity to macrolides, including erythromycin severely impaired hepatic function (see Special warnings and precautions ...

Special warnings and precautions for use

Prolonged or repeated use of antibiotics including roxithromycin may result in superinfection by resistant organisms. In the event of superinfection, roxithromycin should be discontinued and appropriate ...

Interaction with other medicinal products and other forms of interaction

Roxithromycin has a much lower affinity for cytochrome P450 than erythromycin, and consequently has fewer interactions. Interactions may be observed, however, with drugs that bind to alpha-1-acid glycoprotein, ...

Fertility, pregnancy and lactation

Use in pregnancy (Category B1) Reproductive studies in rats, mice and rabbits at doses of 100, 400 and 135 mg/kg/day, respectively, did not demonstrate evidence of developmental abnormalities. In rats, ...

Effects on ability to drive and use machines

Attention should be drawn to the possibility of dizzy sensations.

Undesirable effects

Roxithromycin is generally well tolerated. In clinical trials, treatment discontinuation due to adverse reactions occurred in only 1.2% of adult patients and 1.0% of children. The following side effects ...

Overdose

In case of overdosage, gastric lavage may remove residual drug in the stomach. Clinical monitoring should be considered along with symptomatic and supportive treatment as required. There is no specific ...

Pharmacodynamic properties

Pharmacotherapeutic group: Macrolides ATC code: J01FA06 Microbiology Roxithromycin is a semi-synthetic macrolide antibiotic. Roxithromycin is bacteriostatic at low concentrations and bactericidal at high ...

Pharmacokinetic properties

Absorption Roxithromycin is absorbed after oral administration with an absolute bioavailability of approximately 50%. Peak plasma concentrations following administration of 150 and 300 mg film coated tablets ...

Preclinical safety data

None.

List of excipients

Low substituted hydroxypropyl cellulose (hyprolose) Colloidal anhydrous silica Povidone Purified talc Maize starch Magnesium stearate Hypromellose Anhydrous glucose Titanium dioxide Propylene glycol

Incompatibilities

Not applicable.

Shelf life

24 months.

Special precautions for storage

Store in a cool, dry place where it stays below 25°C, and protect from light and moisture.

Nature and contents of container

PVC/PVdC/Aluminium foil blister strips. Pack size of 10 tablets (150 mg) and 5 tablets (300 mg).

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Teva Pharma (New Zealand) Limited, PO Box 128 244, Remuera, Auckland 1541, Telephone: 0800 800 097

Date of first authorization / renewal of the authorization

28 September 2006

Date of revision of the text

10 February 2017

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