Sominex


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diphenhydramine hydrochloride

Aler-Cap, Aler-Dryl, Allerdryl (CA), AllerMax, Altaryl, Anti-Hist, Banophen, Benadryl, Benadryl Allergy, Benadryl Child Chesty Cough (UK), Benadryl Children's Allergy Fastmelt, Benadryl Dye-Free Allergy, Benadryl Itch Relief, Compoz Nighttime Sleep Aid, Dermamycin, Diphen, Diphenhist, Dytan, Genahist, Histapryn, Histergan (UK), Hydramine, Mandalyn Paedetriac (UK), Nightcalm, Nytol, PMS-Diphenhydramine (CA), Siladryl, Simply Sleep, Sleepeaze (UK), Sleepettes D, Sleepinal, Sominex, Theraflu Thin Strips Multisymptom, Triaminic Thin Strips Children's Cough and Runny Nose, Twilite, Unisom Maximum Strength SleepGels

Pharmacologic class: Ethanolamine derivative, nonselective histamine1-receptor antagonist

Therapeutic class: Antihistamine, antitussive, antiemetic, antivertigo agent, antidyskinetic

Pregnancy risk category B

Action

Interferes with histamine effects at histamine1-receptor sites; prevents but doesn't reverse histamine-mediated response. Also possesses CNS depressant and anticholinergic properties.

Availability

Capsules: 25 mg, 50 mg

Elixir: 12.5 mg/5 ml

Injection: 10 mg/ml, 50 mg/ml

Strips (orally disintegrating): 12.5 mg, 25 mg

Syrup: 12.5 mg/5 ml

Tablets: 25 mg, 50 mg

Tablets (chewable): 12.5 mg, 25 mg

Tablets (orally disintegrating): 12.5 mg

Indications and dosages

Allergy symptoms caused by histamine release (including anaphylaxis, seasonal and perennial allergic rhinitis, and allergic dermatoses); nausea; vertigo

Adults and children over age 12: 25 to 50 mg P.O. q 4 to 6 hours, or 10 to 50 mg I.V. or I.M. q 2 to 3 hours p.r.n. (Some patients may need up to 100 mg.) Don't exceed 400 mg/day.

Children ages 6 to 12: 12.5 to 25 mg P.O. q 4 to 6 hours, or 1.25 mg/kg (37.5 mg/m2) I.M. or I.V. q.i.d. Don't exceed 150 mg/day.

Children ages 2 to 5: 6.25 mg P.O. q 4 to 6 hours. Don't exceed 37.5 mg/day.

Cough

Adults: 25 mg P.O. q 4 hours p.r.n. Don't exceed 150 mg/day.

Children ages 6 to 12: 12.5 mg P.O. q 4 hours. Don't exceed 75 mg/day.

Children ages 2 to 5: 6.25 mg P.O. q 4 hours. Don't exceed 37.5 mg/24 hours.

Dyskinesia; Parkinson's disease

Adults: Initially, 25 mg P.O. t.i.d.; may be increased to a maximum of 50 mg q.i.d.

Mild nighttime sedation

Adults: 50 mg P.O. 20 to 30 minutes before bedtime

Dosage adjustment

• Elderly patients

Off-label uses

• Drug-induced extrapyramidal reactions

Contraindications

• Hypersensitivity to drug
• Alcohol intolerance
• Acute asthma attacks
• MAO inhibitor use within past 14 days
• Breastfeeding
• Neonates, premature infants

Precautions

Use cautiously in:
• severe hepatic disease, angle-closure glaucoma, seizure disorders, prostatic hypertrophy, cardiovascular disease, hyperthyroidism
• elderly patients
• pregnant patients (safety not established)
• children younger than age 2 (safety not established).

Administration

• For motion sickness, administer 30 minutes before activity.
• For I.V. use, check compatibility before mixing with other drugs.
• Inject I.M. dose deep into large muscle mass; rotate sites.
• Discontinue drug 4 days before allergy skin testing to avoid misleading results.

Don't give within 14 days of MAO inhibitors.

Adverse reactions

CNS: drowsiness, dizziness, headache, paradoxical stimulation (especially in children)

CV: hypotension, palpitations, tachycardia

EENT: blurred vision, tinnitus

GI: diarrhea, constipation, dry mouth

GU: dysuria, urinary frequency or retention

Skin: photosensitivity

Other: decreased appetite, pain at I.M. injection site

Interactions

Drug-drug.Antihistamines, opioids, sedative-hypnotics: additive CNS depression

Disopyramide, quinidine, tricyclic antidepressants: increased anticholinergic effects

MAO inhibitors: intensified and prolonged anticholinergic effects

Drug-diagnostic tests.Skin allergy tests: false-negative results

Hemoglobin, platelets: decreased values

Drug-herbs.Angel's trumpet, jimson weed, scopolia: increased anticholinergic effects

Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors.Alcohol use: increased CNS depression

Patient monitoring

• Monitor cardiovascular status, especially in patients with cardiovascular disease.
• Supervise patient during ambulation. Use side rails as necessary.

Patient teaching

• Advise patient to avoid alcohol and other depressants such as sedatives while taking drug.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.


promethazine hydrochloride

Avomine (UK), Histantil (CA), Phenergan (CA), PMS-Promethazine, Promethegan, Sominex (UK), Ziz (UK)

Pharmacologic class: Phenothiazine (nonselective)

Therapeutic class: Antihistamine, antiemetic, sedative-hypnotic

Pregnancy risk category C

FDA Box Warning

• Don't use promethazine in patients younger than age 2 due to potential for fatal respiratory depression. (Postmarketing cases of respiratory depression have been reported in these patients.)

• Use caution when administering to pediatric patients age 2 years and older. Preferably, use lowest effective dosage in these patients and avoid concurrent use of other drugs with respiratory depressant effects.

• Promethazine injection can cause severe chemical irritation and damage to tissue regardless of administration route. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration.

• Adverse reactions to I.V. injection include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, or amputation, has been required.

• Because of risks of I.V. injection, preferred parenteral administration route is deep I.M. injection. Subcutaneous injection is contraindicated.

Action

Blocks effects but not release of histamine and exerts strong alphaadrenergic effect. Also inhibits chemoreceptor trigger zone in medulla and alters dopamine effects by indirectly reducing reticular stimulation in CNS.

Availability

Injection: 25 mg/ml and 50 mg/ml in 1-ml ampules and 1- and 10-ml vials

Suppositories: 12.5 mg, 25 mg, 50 mg

Syrup: 6.25 mg/5 ml

Tablets: 12.5 mg, 25 mg, 50 mg

Indications and dosages

Type 1 hypersensitivity reaction

Adults: 25 mg P.O. or P.R. at bedtime or 12.5 mg P.O. before meals and at bedtime. Or 25 mg I.M. or I.V.; may repeat in 2 hours.

Children older than age 2: 25 mg P.O. or P.R. at bedtime or 6.25 to 12.5 mg P.O. t.i.d.

Motion sickness

Adults: Initially, 25 mg P.O. or P.R. 30 to 60 minutes before traveling; may repeat 8 to 12 hours later if needed. On successive travel days, 25 mg P.O. or P.R. b.i.d. (on arising and before evening meal).

Children older than age 2: 12.5 to 25 mg P.O. or P.R. b.i.d.

Sedation

Adults: 25 to 50 mg P.O., I.M., I.V., or P.R. at bedtime

Children older than age 2: 12.5 to 25 mg P.O. or P.R. at bedtime

Adjunct to preoperative or postoperative analgesia

Adults: 25 to 50 mg P.O., P.R., I.M., or I.V. given with appropriately reduced dosage of narcotic or barbiturate and required dosage of belladonna alkaloid

Children older than age 2: 0.5 mg/lb P.O., P.R., I.M., or I.V., given with appropriately reduced dosage of narcotic or barbiturate and required dosage of belladonna alkaloid

Nausea

Adults: 25 mg P.O. or P.R.; may repeat doses of 12.5 to 25 mg P.O. or P.R. q 4 to 6 hours p.r.n. Or 12.5 to 25 mg I.M. or I.V.; may repeat q 4 hours p.r.n.

Children older than age 2: 25 mg or 0.5 mg/lb P.O. or P.R.; may repeat doses of 12.5 to 25 mg P.O. or P.R. q 4 to 6 hours p.r.n. May give I.M. or I.V. as no more than half of adult dosage. Know that drug should not be given if cause of vomiting is unknown.

Contraindications

• Hypersensitivity to drug
• Previous idiosyncratic reaction to phenothiazines
• Coma
• Intra-arterial and subcutaneous injection
• Children younger than age 2

Precautions

Use cautiously in:
• cardiovascular or hepatic disease, seizures, bone marrow depression, narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal or bladder neck obstruction
• CNS depression caused by narcotics, barbiturates, general anesthesia, tranquilizers, or alcohol
• pregnant or breastfeeding patients.

Administration

• Don't give I.V. at concentrations greater than 25 mg/ml or faster than 25 mg/minute.
• Use light-resistant covering for I.V. drug.

Inject I.M. deep into large muscle. Don't give by subcutaneous route.

Adverse reactions

CNS: confusion, disorientation, fatigue, marked drowsiness, sedation, dizziness, extrapyramidal reactions, insomnia, nervousness, neuroleptic malignant syndrome

CV: hypertension, hypotension, bradycardia, tachycardia

EENT: blurred vision, diplopia, tinnitus

GI: constipation, dry mouth

Hematologic: blood dyscrasias

Hepatic: cholestatic jaundice

Respiratory: respiratory depression

Skin: photosensitivity, rash

Other: hypersensitivity reaction

Interactions

Drug-drug.Anticholinergics: additive anticholinergic effects

CNS depressants: additive CNS depression

Epinephrine: reversal of epinephrine's vasopressor effects

MAO inhibitors: increased extrapyramidal effects

Drug-diagnostic tests.Glucose: increased level

Granulocytes, platelets, white blood cells: decreased counts

Pregnancy test: false-positive or false-negative result

Skin tests using allergen extracts: false-negative results

Drug-herbs.Betel nut: increased risk of extrapyramidal reactions

Evening primrose oil: increased risk of seizures

Kava: increased risk of adverse drug effects

Drug-behaviors.Alcohol use: additive CNS depression

Sun exposure: increased risk of photosensitivity

Patient monitoring

Monitor neurologic status. Stay alert for signs and symptoms of neuroleptic malignant syndrome (high fever, sweating, unstable blood pressure, stupor, muscle rigidity, and autonomic dysfunction).
• In long-term therapy, assess for other adverse CNS effects, including extrapyramidal reactions.
• Monitor CBC and liver function tests.

Patient teaching

Teach patient to recognize and immediately report signs and symptoms of hypersensitivity reaction or neuroleptic malignant syndrome.
• Tell patient about drug's other significant neurologic effects. Instruct him to contact prescriber if these occur.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, alertness, and motor skills.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

Sominex

(sŏm′ĭ-nĕks′)
A trademark for the drug diphenhydramine hydrochloride.

methapyrilene

An ethylenediamine antihistamine and anticholinergic once used in over-the-counter cold medicine and sleeping aids. It was found to be carcinogenic in rats and removed from the market in 1979.

Sominex

A brand name for the antihistamine drug PROMETHAZINE used as a sedative.
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Nytol, along with Sominex, another over-the-counter sleeping pill, is an antihistamine and to my mind is more "physiological" then a standard prescription sleeping pill.
headquarters location, have encouraged patients to consider purchasing alternative products to Glaxo's over-the-counter products, such as Contac cold medicine, Geritol iron supplement, Sominex sleep treatment and Tums antacid.
With regards to Company's Kasai concessions in Zaire, a decision has been made to drop the option on the Sominex alluvial diamond properties.
Nick Mortimer says: For short-term sleeplessness there are other OTC products, such as Nytol (below), Phenergan or Sominex - all are based on antihistamines.
Most non-prescription sleeping aids such as Nytol and Sominex contain antihistamines which block the release of histamine, the brain chemical that keeps us awake.
In other developments in Zaire, Management reports that an evaluation team, consisting of 27 people, is on-site conducting a preliminary evaluation of the Kasai River alluvial diamond concessions as per the Company's agreement with Sominex SPRL dated March 5, 1996.
VSE:SCQ) (the "Company") is pleased to announce that it has been granted an option by Sominex S.