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PHARMACOLOGY
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Framycetin, a broad-spectrum amino glycoside antibiotic, is usually bactericidal in action. Although the exact mechanism of action has not been fully elucidated, the drug appears to inhibit protein synthesis in susceptible bacteria by binding to ribosomal subunits. In general, framycetin is active against many aerobic gram-negative bacteria and some aerobic gram-positive bacteria. The drug is inactive against fungi, viruses, and most anaerobic bacteria. Gramicidin is a cyclic polyceptide antibiotic. It alters the cation content of the bacterial cell wall. Gramicidin is primarily effective against gram-positive organisms. Phenylephrine is a sympathomimetic amine which acts predominanly on alpha-adrenergic receptors. Topical application to the nasal mucosa results in the constriction of dilated arterioles and reduction in nasal congestion. In addition, nasal secretions are reduced, and drainage of sinus secretion is increased. Nasal ventilation and aeration are improved temporarily. |
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INDICATIONS AND CLINICAL USE |
For use in the local treatment of infections and/or congestion caused by susceptible organisms in acute rhino-sinusitis, crusting rhinitis, nasal conditions accompanying the common cold and post-operative care of patients who have undergone intranasal or sinus surgery. Prophylactic use for reduction of nasal carriage of staphylococci. |
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CONTRAINDICATIONS
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Known hypersensivity to any ingredients
of the preparation (see also PRECAUTIONS).
It should not be administered to children under 2 years of age, to patients receiving MAO inhibitors, to patients presenting narrow angle glaucoma or rhinitis sicca. |
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PRECAUTIONS
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Cross sensitization may occur among
the group of Streptomyces derived antibiotics (neomycin, paromomycin,
kanamycin) of which framycetin is a member, but this is not invariable.
Prolonged use of antibiotics may result in the overgrowth of nonsusceptible
organism, including fungi. Appropriate measures should be taken if this
occurs.
Because some individuals may be particularly sensitive to the effects of sympathomimetics, use nasal spray with caution in patients with marked hypertension, hyperthyroidism, unstable type 1 diabetes mellitus, and severe coronary artery disease and in those receiving tricyclic antidepressants. Clinical data are inadequate to establish conditions for safe use in pregnant and lactating woman. |
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ADVERSE REACTIONS
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The following adverse effects may occur
: transient burning, stinging, dryness of the nasal mucosa and sneezing.
As with other topical nasal decongestants, palpitations, tachycardia, cardiac arrythmias, increase in blood pressure, headache, light-headedness, nervousness, insomnia, blurred vision, drowsiness and CNS depression are a possibilitywith high doses. |
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DOSAGE AND ADMINISTRATION
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Usual adult dosage Two(2) sprays
in each nostril every 4 hours. Maximum of 6 times per day.
For reduction of staphylococci nasal carriage : 2 sprays in each nostril twice daily. As for any other preparation containing phenylephrine hydrochloride or related compounds, intranasal application should generally be used for no longer than 3-5 days, since it can result in rebound congestion (which may lead to rhinitis medicamentosa). |
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AVAILABILITY OF DOSAGE FORMS
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15 mL spray pump Each mL contains
: framycetin 12,5 mg (as sulphate BP), gramicidin USP 50 mcg and phenylephrine
hydrochloride BP 2,5 mg and benzalkonium chloride as preservative in a
buffered isotonic saline solution.
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STORAGE
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Store between 15° and 25°C
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Instructions for use SOFRAMYCIN (SPRAY NASAL) |
The flask of Soframycin Nasal spray contains a tip covered with a hood. The tip rests on a horizontal base, so presenting two zones of support. The index and the major will take support on the horizontal base on both sides of the tip, the thumb on the basis of the flask. Introduce the tip into the nostril; rest with fingers to obtain evaporations. |
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