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Al-Tinez Triamcinolone Mouthpaste

Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name

Al-Tinez Triamcinolone Mouthpaste

Manufacturer

Medipharco 8 Nguyen Truong To St., Hue City, Vietnam.

Therapeutic Class

Corticosteroids, Oral gel

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Oral gel (NRN: A4-4964): Each tube 5g contains: Triamcinolone acetonide  5 mg Excipients s.q.f 5g.

Pack size: 5g tube in a box.

mouthpaste

Pharmacology

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.

Synthetic analogs such as triamcinolone are primarily used for their anti-inflammatory effects in disorders of many organ systems.

Indications

Treatment of aphthous ulcers and denture stomatitis, erosive lichen planus, desquamative gingivitis and traumatic lesions.

Mouth ulcers and sores caused by dentures (false teeth) or injuries.

Gum condition involving shedding of the surface of the gums, soreness and inflammation of the gums (desquamative gingivitis).

Contra-indications

Hypersensitivity to any ingredient.

People with bacterial or fungal infections in the mouth or throat, unless this is being treated with antibiotics or antifungal medicine.

Do not use in the eyes.

Precautions/Warnings

Do not eat or drink immediately after applying Al-Tinez mouthpaste gel

Corticosteroids can be absorbed into the bloodstream if they are used in large amounts, for long periods of time, or if the treated area is covered, for example with dentures. For this reason, this medicine should be used sparingly and for short periods of time only, particularly in elderly people and children, who are more susceptible to side effects.

Do not use for longer than five days in children.

People with an unexplained mouth ulcer that has lasted longer than three weeks should seek advice from their doctor.

Use carefully in patients with disorders of thyroid glands.

Pregnancy and Lactation:

Certain medicines should not be used during pregnancy or lactation. However, other medicines may be safely used in pregnancy or lactation providing the benefits to the mother outweigh the risks to the unborn baby.

Always inform your doctor if you are pregnant or breast-feeding, before using any medicine. The safety of this medicine for use during pregnancy and lactation has not been established. Seek medical advice from your doctor.

Interactions

Aminoglutethimide:

Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.

Amphotericin B injection and potassium-depleting agents:When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Antibiotics:

Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.

Anticholinesterases:

Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.

Anticoagulants, oral:

Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

Antidiabetics:

Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

Antitubercular drugs:

Serum concentrations of isoniazid may be decreased.

Cholestyramine:

Cholestyramine may increase the clearance of corticosteroids.

Cyclosporine:

Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

Digitalis glycosides:

Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Estrogens, including oral contraceptives:

Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.

Hepatic enzyme inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin):

Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.

Ketoconazole:

Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.

Nonsteroidal anti-inflammatory drugs (NSAIDS):

Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.

Adverse Effects

The following are some of the side effects that are known to be associated with this medicine, including: itching, thick hair.

Allergic reaction: Rarely happens.

Inform your doctor of any adverse reaction related to drug use.

Dosage & Administration

Apply a thin layer on the affected areas 2-3 times a day.

It should not be used constantly over 8 days and do not apply the gel on a large area.

Storage/Handling Recommendations

Store in a dry place, below 30°C, protected from light.

Shelf life: 36months

Read the instructions carefully before using. For further information, consult the physician.

Review Date

2016-05-10 07:19:08