The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation.
Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.
HYOSYNE ORAL DROPS
(Hyoscyamine Sulfate Oral Solution)
Dosage may be adjusted according to the conditions and severity of symptoms. Measuredosage very carefully.
Adults and pediatric patients 12 years of age and older: 1 to 2 mL every four hours or as needed. Do not exceed 12 mL in 24 hours.
Pediatric patients 2 to under 12 years of age: 1/4 to 1 mL every four hours or as needed. Do not exceed 6 mL in 24 hours.Pediatric patients under 2 years of age: The following dosage guide is based upon body weight. The doses may be repeated every four hours or as needed.
|Body Weight||Usual Dose||Do Not Exceed|
|In 24 Hours|
|3.4 kg (7.5 lb.)||4 drops||24 drops|
|5 kg (11 lb.)||5 drops||30 drops|
|7 kg (15 lb.)||6 drops||36 drops|
|10 kg (22 lb.)||8 drops||48 drops|
Package of Hyoscyamine Sulfate Oral Drops is accompanied with a dropper having markings of 3, 4, 5 DROPS, and 0.25 mL. The approximate equivalent amount of hyoscyamine sulfate drops (mL) and its equivalent amount of hyoscyamine sulfate (mg) for each marking are as follows:
|Approximate Equivalent Amount|
|Marking on Dropper||Hyoscyamine Sulfate Oral Drops Solution (mL)||Hyoscyamine Sulfate (mg)|
|3 DROPS||0.08 mL||0.01 mg|
|4 DROPS||0.11 mL||0.01375 mg|
|5 DROPS||0.14 mL||0.0175 mg|
|0.25 mL||0.25 mL||0.03125 mg|
(Hyoscyamine Sulfate Elixir)
Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully.
Adults and pediatric patients 12 years of age and older: 1 to 2 teaspoonfuls every four hours or as needed. Do not exceed 12 teaspoonfuls in 24 hours.Pediatric patients 2 to under 12 years of age: Please see the following dosage guide is based on body weight. The doses may be repeated every four hours or as needed. Do not exceed 6teaspoonfuls in 24 hours.
|Body Weight||Usual Dose|
|10 kg (22 lb.)||1/4 teaspoon (1.25 mL)|
|20 kg (44 lb.)||1/2 teaspoonful (2.5 mL)|
|40 kg (88 lb.)||3/4 teaspoonful (3.75 mL)|
|50 kg (110 lb.)||1 teaspoonful (5 mL)|
HYOSYNE ORAL DROPS (Hyoscyamine Sulfate 0.125 mg per mL) is orange colored, flavored, and contains 5% alcohol. It is supplied in a 15 mL bottle with a calibrated dropper
HYOSYNE ELIXIR (Hyoscyamine Sulfate 0.125 mg per 5 mL) is orange colored, flavored, and contains 20% alcohol. It is supplied in a pint (473 mL) bottle.
Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
Silarx Pharmaceuticals, Inc.Carmel, NY 10512
Miami, Fl 33179
|HYOSYNE hyoscyamine sulfate elixir|
|Labeler — ATLANTIC BIOLOGICALS CORP. (047437707)|
|ATLANTIC BIOLOGICALS CORP.||047437707||repack (17856-0514), relabel (17856-0514)|
Revised: 06/2021 ATLANTIC BIOLOGICALS CORP.
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