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Flavox (Flavoxate Hydrochloride)

Pharmacology:

Flavox film coated tablet contains Flavoxate Hydrochloride, a synthetic urinary tract spasmolytic. Flavoxate Hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on muscle.

Composition:

Flavox 100 Tablet: Each film coated tablet contains Flavoxate Hydrochloride BP 100 mg.

Flavox 200 Tablet: Each film coated tablet contains Flavoxate Hydrochloride BP 200 mg.

Indication:

1. Urinary incontinence

2. Excessive urination at night (nocturia)

3. Pain in the bladder

4. Pain or difficulty in urination (dysuria)

5. Passing urine too frequently (urinary frequency)

6. Spasms of the bladder or urethra due to catheters or urinary tract surgery

7. Uncontrollable urge to pass urine (urinary urgency)

8. Other symptoms associated with cystitis, prostitis, urethritis and bladder infections

9. It is not indicated for definitive treatment of urinary tract infection but are compatible with drugs used for the treatment of urinary tract infections

Dosage and Administration:

The usual dosage of Flavox for patients older than 12 years of age is 100-200 mg 3 or 4 times daily. Dosage may be reduced as symptoms improve.

In patients with infections, treatment is usually continued for as long as antibacterial or antiinfective medications are administered. In patients with chronic bladder symptoms, maintenance therapy for prolong periods may be required for optimum results. With improvement of symptoms, the dose may be reduced.

Contraindication:

The drug is contraindicated in patients with pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, GI hemorrhage, or obstructive uropathies of the lower urinary tract.

Side Effect:

Side effects of Flavoxate Hydrochloride include nausea and vomiting, dry mouth and throat, nervousness, vertigo, headache, drowsiness, blurred vision, increased ocular tension, disturbance in ocular accommodation, urticaria and other dermatoses, mental confusion, dysuria, tachycardia and palpitation, hyperpyrexia, and eosinophilia. Rarely, abdominal pain and difficulty in concentration may occur. Constipation has been reported in patients receiving 800 mg to 1.2 g of Flavoxate Hydrochloride daily.

Precaution:

Because of possible drowsiness, vertigo, and ocular disturbances, Flavoxate Hydrochloride should be administered with caution to patients performing hazardous tasks requiring mental alertness or physical coordination. Flavoxate Hydrochloride should also be administered with caution to patients with suspected glaucoma.

Use in Pregnancy, Lactation and Children:

Pregnancy: There are no well-controlled studies using Flavoxate Hydrochloride in pregnant women and therefore the drug should be used during pregnancy only when clearly needed.

Lactation: Since it is not known whether Flavoxate Hydrochloride is distributed into milk, the drug should be used with caution in nursing women.

Children: Safety in children under 12 years of age has not been established.

Drug Interaction:

No interactions has been noted.

Overdose:

Symptoms of overdose may include unusually dry mouth, excessive thirst, nausea, vomiting, difficulty in breathing, blurred vision, dilated pupils, flushed, dry skin, muscle weakness, unusual dizziness or drowsiness, restlessness, disorientation and seizures.

Packaging:

Flavox 100 Tablet: Box containing 3 x 10 Tablets in alu-PVDC pack.

Flavox 200 Tablet: Box containing 2 x 10 Tablets in alu-PVDC pack.

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