My Wife Vomiting often in A Day, This Medication Helps Her during the Pregnancy - 12 Weeks Now
Contents
Meclozine hydrochloride, pyridoxine hydrochloride.
Meclozine hydrochloride, pyridoxine hydrochloride.
Description
Each tablet contains: Meclozine Hydrochloride 25 mg.
Pyridoxine Hydrochloride 50 mg.
Action
Pharmacology: Meclozine is a piperazine derivative with the properties of antihistamines. It has Central Nervous System (CNS) depressant, anticholinergic, antiemetic, antispasmodic, and local anesthetic effects in addition to antihistaminic activity. The drug depresses labyrinth excitability and conduction in vestibular-cerebellar pathways. The antiemetic and antimotion-sickness actions of Meclozine result, at least in part, from its central anticholinergic and CNS depressant properties. The onset of action of Meclozine is about 1 hour and the drug has prolonged duration of action, with effects persisting 8 to 24 hours following administration of a single oral dose. The drug has a plasma half-life of 6 hours. The metabolic rate of Meclozine in humans is unknown. In rats, Meclozine is metabolized (probably in the liver) to norchlorcyclizine. This metabolite is distributed throughout most body tissues and crosses the placenta. The drug is excreted in faeces unchanged and in urine as norchlorcyclizine. Pyridoxine is a water-soluble, B complex vitamin. It has been used for the management of vertigo, motion sickness, depression associated with pregnancy. Pyridoxine is readily absorbed from the gastrointestinal (GI) tract after oral doses and is converted to the active forms pyridoxal phosphate and pyridoxamine phosphate. They are stored mainly in the liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites which are excreted in the urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.
Pharmacology: Meclozine is a piperazine derivative with the properties of antihistamines. It has Central Nervous System (CNS) depressant, anticholinergic, antiemetic, antispasmodic, and local anesthetic effects in addition to antihistaminic activity. The drug depresses labyrinth excitability and conduction in vestibular-cerebellar pathways. The antiemetic and antimotion-sickness actions of Meclozine result, at least in part, from its central anticholinergic and CNS depressant properties. The onset of action of Meclozine is about 1 hour and the drug has prolonged duration of action, with effects persisting 8 to 24 hours following administration of a single oral dose. The drug has a plasma half-life of 6 hours. The metabolic rate of Meclozine in humans is unknown. In rats, Meclozine is metabolized (probably in the liver) to norchlorcyclizine. This metabolite is distributed throughout most body tissues and crosses the placenta. The drug is excreted in faeces unchanged and in urine as norchlorcyclizine. Pyridoxine is a water-soluble, B complex vitamin. It has been used for the management of vertigo, motion sickness, depression associated with pregnancy. Pyridoxine is readily absorbed from the gastrointestinal (GI) tract after oral doses and is converted to the active forms pyridoxal phosphate and pyridoxamine phosphate. They are stored mainly in the liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites which are excreted in the urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.
Indications/Uses
For the prevention and treatment of nausea, vomiting or vertigo associated with motion sickness and other vestibular disorders.
For the prevention and treatment of nausea, vomiting or vertigo associated with motion sickness and other vestibular disorders.
Dosage/Direction for Use
For oral administration only.
Motion Sickness: Adults: Take 1 to 2 tablets once daily, 1 hour before traveling or exposure to motion. This dose may be repeated every 24 hours if necessary. Children 6 to 12 years: Give 1/2 to 1 tablet once daily, 1 hour before traveling or exposure to motion or as directed by physician. Vertigo and Vestibular Disorders: Adults: Take 1 to 4 tablets daily in divided doses or as directed by physician. Take each dose with a full glass of water. Do not exceed the recommended dose unless otherwise prescribed by physician.
For oral administration only.
Motion Sickness: Adults: Take 1 to 2 tablets once daily, 1 hour before traveling or exposure to motion. This dose may be repeated every 24 hours if necessary. Children 6 to 12 years: Give 1/2 to 1 tablet once daily, 1 hour before traveling or exposure to motion or as directed by physician. Vertigo and Vestibular Disorders: Adults: Take 1 to 4 tablets daily in divided doses or as directed by physician. Take each dose with a full glass of water. Do not exceed the recommended dose unless otherwise prescribed by physician.
Overdosage
Sign and Symptoms of Overdose and Treatment: In adults, the usual signs of Meclozine overdose are CNS depression with drowsiness, coma and convulsions. Hypotension may also occur, particularly in the elderly. In children, anticholinergic effects and CNS stimulation (hallucinations, seizures, trouble sleeping) are more likely to occur. Symptoms of a pyridoxine overdose may include poor coordination, staggering, numbness, decreased sensation to touch, temperature and vibration. There is no specific antidote for treatment of overdosage. Symptomatic and supportive treatment should be employed.
Sign and Symptoms of Overdose and Treatment: In adults, the usual signs of Meclozine overdose are CNS depression with drowsiness, coma and convulsions. Hypotension may also occur, particularly in the elderly. In children, anticholinergic effects and CNS stimulation (hallucinations, seizures, trouble sleeping) are more likely to occur. Symptoms of a pyridoxine overdose may include poor coordination, staggering, numbness, decreased sensation to touch, temperature and vibration. There is no specific antidote for treatment of overdosage. Symptomatic and supportive treatment should be employed.
Contraindications
Not suitable for patients who have known hypersensitivity to Meclozine or Pyridoxine.
Not suitable for patients who have known hypersensitivity to Meclozine or Pyridoxine.
Special Precautions
If symptoms persist, please consult a physician. This medicine may cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drinks. It should be used with caution for patients with asthma, angle-closure glaucoma or prostatic hypertrophy. Patient should be warned that Meclozine may impair their ability to perform hazardous activities requiring mental alertness or physical coordination.
Long-term use of large doses of Pyridoxine is associated with the development of severe peripheral neuropathies.
If symptoms persist, please consult a physician. This medicine may cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drinks. It should be used with caution for patients with asthma, angle-closure glaucoma or prostatic hypertrophy. Patient should be warned that Meclozine may impair their ability to perform hazardous activities requiring mental alertness or physical coordination.
Long-term use of large doses of Pyridoxine is associated with the development of severe peripheral neuropathies.
Use In Pregnancy & Lactation
Use in Pregnancy: Meclozine is classified by FDA as category B. There are no adequate and well-controlled studies in pregnant women or animals studies which have shown an adverse effect. This means that it is not expected to harm an unborn baby. Pyridoxine is classified by FDA as category A. Therefore, it is considered to be safe for use during pregnancy. Pyridoxine requirements increase during pregnancy.
Use in Pregnancy: Meclozine is classified by FDA as category B. There are no adequate and well-controlled studies in pregnant women or animals studies which have shown an adverse effect. This means that it is not expected to harm an unborn baby. Pyridoxine is classified by FDA as category A. Therefore, it is considered to be safe for use during pregnancy. Pyridoxine requirements increase during pregnancy.
Use in Lactation:
Meclozine may be distributed into breast milk. However, problems in humans have not been documented. Due to its anticholinergic actions, Meclozine may inhibit lactation. Therefore, it is not recommended for lactating women unless the expected benefits outweigh any potential risk.
Pyridoxine is excreted into milk. While some have expressed concern over the inhibition of breast milk secretion by Pyridoxine, others have cautioned that Pyridoxine deficiency may cause seizures in neonate.
Pyridoxine is excreted into milk. While some have expressed concern over the inhibition of breast milk secretion by Pyridoxine, others have cautioned that Pyridoxine deficiency may cause seizures in neonate.
Adverse Reactions
Drowsiness, dry mouth, headache and GI disturbances have been reported and rarely caused blurred vision.
Drowsiness, dry mouth, headache and GI disturbances have been reported and rarely caused blurred vision.
Drug Interactions
Meclozine has an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIs). It may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. In addition, the additive CNS depression may occur when Meclozine is administered concomitantly with other CNS depressants including barbiturates, tranquilizers, and alcohol. If Meclozine is used concomitantly with other depressant drugs, caution should be used to avoid overdosage. Pyridoxine reduces the effects of levodopa, but this does not occur if a dopa decarboxylase inhibitor is also given. Pyridoxine reduces the activity of altretamine. It has also been reported to decrease serum concentrations of phenobarbital and phenytoin. Some drugs may increase the requirements for Pyridoxine; such drugs include hydralazine, isoniazid, penicillamine, and oral contraceptives.
Meclozine has an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIs). It may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. In addition, the additive CNS depression may occur when Meclozine is administered concomitantly with other CNS depressants including barbiturates, tranquilizers, and alcohol. If Meclozine is used concomitantly with other depressant drugs, caution should be used to avoid overdosage. Pyridoxine reduces the effects of levodopa, but this does not occur if a dopa decarboxylase inhibitor is also given. Pyridoxine reduces the activity of altretamine. It has also been reported to decrease serum concentrations of phenobarbital and phenytoin. Some drugs may increase the requirements for Pyridoxine; such drugs include hydralazine, isoniazid, penicillamine, and oral contraceptives.
Storage
Store below 30°C. Protect from direct sunlight, heat and moisture.Shelf-Life: 3 years from the date of manufacture.
Store below 30°C. Protect from direct sunlight, heat and moisture.Shelf-Life: 3 years from the date of manufacture.
MIMS Class
Antiemetics / Antivertigo Drugs
Antiemetics / Antivertigo Drugs
ATC Classification
R06AE55 - meclozine, combinations ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
R06AE55 - meclozine, combinations ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Regulatory Classification
C
C
Presentation/Packing
Tab (white coloured, round with flat surface on both sides and scored on one side) 1 x 10's, 10 x 10's.
Tab (white coloured, round with flat surface on both sides and scored on one side) 1 x 10's, 10 x 10's.
Indications and Dosage
Oral
Treatment and prophylaxis of motion sickness, Nausea and vertigo caused by Meniere's disease
Adult: 50-100 mg 6-8 hourly. As prophylaxis for motion sickness: Give 30 minutes to 1 hour prior to activity. Max: 400 mg daily.
Child: 2-6 years 12.5-25 mg 6-8 hourly. Max: 75 mg daily; 6-<12 years 50 mg 6-8 hourly. Max: 150 mg daily; ≥12 years Same as adult dose.
Parenteral
Treatment and prophylaxis of motion sickness, Nausea and vertigo caused by Meniere's disease
Adult: 50-100 mg 4 hourly via IM or slow IV inj over 2 minutes. Max: 100 mg 4 hourly.
Child: 1.25 mg/kg or 37.5 mg/m2 4 times daily via IM inj. Max: 300 mg daily.
Administration
May be taken with or without food.
Reconstitution
IV inj: Dilute a 50 mg vial with 10 mL of 0.9% NaCl soln.
Incompatibility
Incompatible with aminophylline, glycopyrronium bromide, hydrocortisone Na succinate, hydroxyzine, meglumine adipiodone, phenothiazines and soluble barbiturates.
Special Precautions
Patient with history of asthma or lower respiratory tract symptoms (e.g. emphysema, chronic bronchitis), angle-closure glaucoma, prostatic hypertrophy, bladder neck obstruction, stenosing peptic ulcer, pyloroduodenal obstruction, cardiovascular disease (e.g. cardiac arrhythmias, hypertension, ischaemic heart disease), seizure, thyroid dysfunction. Children. Pregnancy and lactation. Hepatic impairment.
Adverse Reactions
Cardiac disorders: Tachycardia.
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Dry mouth, nose, throat; epigastric distress, nausea.
General disorders and admin site conditions: Lassitude.
Nervous system disorders: Drowsiness, excitement, headache.
Psychiatric disorders: Nervousness, restlessness, insomnia (children), confusion.
Renal and urinary disorders: Painful urination.
Respiratory, thoracic and mediastinal disorders: Thickening of bronchial secretions.
Skin and subcutaneous tissue disorders: Rash.
Pregnancy Category (US FDA)
IM/IV/Parenteral/PO/Rectal: B
Patient Counseling Information
This drug may cause drowsiness and dizziness, if affected, do not drive or operate machinery.
Overdosage
Symptoms: Drowsiness, hallucination, severe delirium, extrapyramidal symptoms, vomiting, vertigo, convulsions, coma, respiratory depression. Management: May induce emesis or perform gastric lavage within 3 hours after ingestion. Administer oxygen and initiate mechanically assisted respiration in respiratory depression. Administration of vasopressors may be use to treat hypotension. Administer diazepam for convulsions or phenobarbital (5-6 mg/kg) in paediatric patients.
Drug Interactions
Concomitant use with antibiotics may cause ototoxicity and dimenhydrinate may mask ototoxicity symptoms . Enhanced adverse effect (e.g. drowsiness) of other CNS depressants. May prolong and intensify the antimuscarinic effects with MAOIs and other antimuscarinic agents (e.g. atropine, TCA).
Food Interaction
Enhanced CNS depressant effect of alcohol.
Action
Description: Dimenhydrinate, a monoethanolamine derivative, is a sedating antihistamine with antimuscarinic and significant sedative effects. It competes with histamine in binding for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. It has central anticholinergic activity which blocks chemoreceptor trigger zone, diminishes vestibular stimulation and reduces labyrinth function.
Onset: Antiemetic: Oral: 15-30 minutes; IM: 20-30 minutes.
Duration: 4-6 hours.
Pharmacokinetics: Absorption: Well absorbed from the gastrointestinal tract . Time to peak plasma concentration: Approx 1 hour.
Distribution: Crosses the placenta and present in breastmilk (small amounts). Volume of distribution: 3-4 L/kg. Plasma protein binding: 70-85%.
Metabolism: Extensively metabolised in the liver to diphenyl-methoxy-ethylamine, diphenyl-methoxy-acetic, and diphenyl-methoxy-N-methylamine.
Excretion: Via urine. Elimination half-life: 5-8 hours.
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Importance Metoclopramide, a drug frequently used for nausea and vomiting in pregnancy, is thought to be safe, but information on the risk of specific malformations and fetal death is lacking.
Objective To investigate the safety of metoclopramide use in pregnancy.
Design, Setting, and Participants Register-based cohort study in Denmark, 1997-2011. From a cohort of 1 222 503 pregnancies, metoclopramide-exposed and unexposed women were matched (1:4 ratio) on the basis of age, calendar year, and propensity scores.
Main Outcomes and Measures Primary outcomes were major congenital malformations overall, 20 individual malformation categories (selected according to power criteria), spontaneous abortion, and stillbirth. In matched analyses, logistic regression was used to estimate prevalence odds ratios of malformations and Cox regression to estimate hazard ratios (HRs) of spontaneous abortion.
Contents
Folic acid.
Description
Each tablet contains Folic acid 5 mg.
Indications/Uses
It is indicated for the treatment of megaloblastic anaemia caused by deficiency of folic acid. It is also indicated in pregnancy to supply a maintenance dosage of folic acid.
Dosage/Direction for Use
In the treatment of megaloblastic anaemia, folic acid may be given in an initial dosage of 10 to 20 mg daily for 14 days, or until a haemopoietic response is obtained. The daily maintenance dose is 2.5 to 10 mg. Children may be given 5 to 15 mg daily according to the severity of the deficiency state. For maintenance dosage in pregnancy, folic acid may be given in dosage of 5 mg daily during first trimester of pregnancy.
Administration: Oral.
Overdosage
The possibility of serious toxic effects due to overdosage appears remote.
Treatment: An emetic should be administered as soon as possible following by gastric lavage if possible.
Contraindications
It is contraindicated in patients who are sensitive to it.
Special Precautions
Folic acid should never be given alone or in conjunction with inadequate amounts of hydroxocobalamin for the treatment of megaloblastic or pernicious anaemia. Though folic acid produces a haemopoietic response, it fails to prevent the onset of subacute combined degeneration of the cord. Folic acid should not be given before a diagnosis has been fully established. Large and continuous doses of folic acid may lower the blood concentration of vitamin B12. The availability of folates may be inhibited by gastric acidity and the presence of ascorbate in the gastrointestinal tract.
Metformin reduces intestinal absorption of folic acid and phenytoin may cause folate depletion. Folic acid does not correct folate deficiency due to dihydrofolate reductase inhibitors.
Adverse Reactions
Folic acid is usually well tolerated. However, allergic sensitization has been reported following oral administration.
View ADR Monitoring Form
Storage
Store below 30°C.
Shelf-Life: 5 years.
MIMS Class
Vitamins & Minerals (Pre & Post Natal) / Antianemics
ATC Classification
B03BB01 - folic acid ; Belongs to the class of folic acid and derivatives. Used in the treatment of anemia.
Presentation/Packing
Tab 5 mg (Round, pale yellow, standard convex, plain with score on one side) x 1000's.
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