SULTAN Capsules

Description

PHARMACOLOGICAL ACTION:
SULTAN capsules contain diphenhydramine, which is a prototype potent antihistaminic that blocks the action of histamine, one of the most important chemical mediators contributing to the ensuing symptoms associated with allergy and hypersensitivity reactions. Because of the rapid onset of action of SULTAN capsules, it provides prompt relief of itching, prevention of urticaria and other allergic manifes¬tations. Beneficial effects of SULTAN are exerted on mucous glands in the nasal mucosa and the nasal blood vessels due to its effect on sensitized mast cells and basophils and its weak anticholinergic effect which lessens rhinorrhea. SULTAN produces sedative effect.
PHARMACOKINETICS:
Diphenhydramine hydrochloride is well absorbed from gastrointestinal tract, although high first-pass metabolism appears to affect systemic availability. Peak plasma concentration are achieved about 1 to 4 hours after oral doses. Diphenhydramine hydrochloride is widely distributed throughout the body including the CNS. It crosses the placenta and has been detected in breast milk. Diphenhydramine hydrochloride is highly bound to plasma proteins. Metabolism is extensive. Diphenhydramine hydrochloride is excreted mainly in the urine as metabolites. Little is excreted as unchanged drug. The elimination half-life has been reported to range from 2.4 to 9.3 hours.
INDICATIONS:
• Allergic rhinitis as perennial and seasonal rhinitis and other allergic rhinopathies.
• Allergic skin manifestations including pruritus, urticaria, drug allergy, chronic idiopathic urticaria, symptomatic dermographism and itching of atopic eczema.
• Local allergic reactions to insect bites and stings.
• Nighttime sleep aid.
DOSAGE & ADMINISTRATION:
1 capsule 3-4 times daily.
For nighttime sleep aid; 1 capsule to be taken 20 minutes before going to bed.
CONTRAINDICATIONS:
• Breathing problems, glaucoma and prostatic hypertrophy unless directed by doctor.
• In children under 12 years.

SIDE EFFECTS:
General: Urticaria, rash, anaphylactic shock, photosensitivity, chills, dryness of mouth, nose and throat.
Cardiovascular system: Hypotension, headache, palpitations, tachycardia.
Heamtological system: Agranulocytosis, hemolytic anemia, thrombocytopenia.
Nervous system: Sedation, sleepiness, dizziness, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, blurred vision.
GIT: Epigastric stress, anorexia, nausea, vomiting, diarrhea or constipation, increased gastric reflux.
Urinary system: Urinary frequency, difficult urination, urinary retention.
Respiratory system: Thickness of bronchial secretions, tightness of chest and wheezing, nasal stuffness.
DRUG INTERACTIONS:
SULTAN capsules produces additive CNS effects when taken concomitantly with alcohol, sedatives or tranquilizers.

PREGNANCY & LACTATION:
SULTAN is contraindicated in pregnancy and lactation.

PRECAUTIONS & WARNINGS:
 Drowsiness is a major problem with SULTAN capsules and those affected should not drive or operate machinery, alcohol should be avoided.
 Dosage reduction may be necessary in renal impairment, caution is also needed in hepatic impairment.
 Diphenhydramine hydrochloride has an atropine – like action and therefore should be used with caution in patients with a history of lower respiratory disease including asthma, increased ocular pressure, hyperthyroidism, cardiovascular disease or hypertension.
 Diphenhydramine hydrochloride should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction.

PACKING:
A carton box containing 20 capsules in 2 PVC/Aluminium strips.

STORAGE:
Keep at a temperature not exceeding 30C, in dry place.
Keep out of reach of children.

INSTRUCTIONS TO PATIENTS:
Use caution in performing activities requiring alertness.