Vomex

Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine (Vomex) has also been administered in veterinary applications and was formerly used in parkinsonism. [PubChem]

A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (poaceae). Folic Acid (Vomex) is used in the treatment and prevention of folate deficiencies and megaloblastic anemia. [PubChem]

The 4-methanol form of vitamin B 6 which is converted to pyridoxal phosphate which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).

Hypertension: this medicine is indicated for the treatment of hypertension.

Heart Failure:

this medicine is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and when appropriate, digitalis and beta-blockers.

Myocardial Infarction:

-Short -term (4 weeks) treatment: this medicine is indicated in any clinically stable patients within the first 24 hours of an infarction.

-Long term prevention of symptomatic heart failure: this medicine is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction <40%).

Type I Diabetic Nephropathy:

this medicine is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes..

Folic Acid (Vomex) is used in the treatment and prevention of the folate deficiency state. It does not correct folate deficiency due to dihydrofolate reductase inhibitors. Folic Acid (Vomex) is also used in women of child-bearing potential and pregnant women to protect against neural tube defects in their offspring. It is also used for the treatment of folate-deficient megaloblastic anaemia, chronic haemolytic states such as thalassaemia major or sickle-cell anaemia.

* Sideroblastic anaemia

* Treatment and prophylaxis of Vitamin B6 (Vomex) deficiency states

Doxylamine (Vomex) is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Antihistamines can cause drowsiness and are sometimes used a sleep aids.

Doxylamine (Vomex) is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Doxylamine (Vomex) is also used as a short-term treatment for sleep problems (insomnia).

Doxylamine (Vomex) may also be used for purposes not listed in this medication guide.

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Folic Acid (Vomex) (vitamin B 9) is necessary for strong blood.

Lack of Folic Acid (Vomex) may lead to anemia (weak blood). Your health care professional may treat this by prescribing Folic Acid (Vomex) for you.

Some conditions may increase your need for Folic Acid (Vomex). These include:

• Alcoholism
• Anemia, hemolytic
• Diarrhea (continuing)
• Fever (prolonged)
• Hemodialysis
• Illness (prolonged)
• Intestinal diseases
• Liver disease
• Stress (continuing)
• Surgical removal of stomach

In addition, infants smaller than normal, breast-fed infants, or those receiving unfortified formulas (such as evaporated milk or goat's milk) may need additional Folic Acid (Vomex).

Increased need for Folic Acid (Vomex) should be determined by your health care professional.

Some studies have found that Folic Acid (Vomex) taken by women before they become pregnant and during early pregnancy may reduce the chances of certain birth defects (neural tube defects).

Claims that Folic Acid (Vomex) and other B vitamins are effective for preventing mental problems have not been proven. Many of these treatments involve large and expensive amounts of vitamins.

Injectable Folic Acid (Vomex) is given by or under the direction of your health care professional. Another form of Folic Acid (Vomex) is available without a prescription.

Pyridoxine is Vitamin B6 (Vomex). Vitamins occur naturally in foods such as meat, poultry, nuts, whole grains, bananas, and avocados. Vitamin B6 (Vomex) is important for many processes in the body.

Pyridoxine is used to treat or prevent Vitamin B6 (Vomex) deficiency. It is also used to treat a certain type of anemia (lack of red blood cells). Pyridoxine injection is also used to treat some types of seizure in babies.

Pyridoxine taken by mouth (oral) is available without a prescription. Injectable pyridoxine must be given by a healthcare professional.

Pyridoxine may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Allergic Rhinitis

Doxylamine (Vomex) 5 mg oral tablet, chewable:

10 mg orally every 4 to 6 hours not to exceed 6 doses daily.

Usual Adult Dose for Allergic Conjunctivitis

Doxylamine (Vomex) 5 mg oral tablet, chewable:

10 mg orally every 4 to 6 hours not to exceed 6 doses daily.

Usual Adult Dose for Insomnia

12 years of age and older: 25 mg orally 30 minutes before bed

Maximum dose: Take once daily or as directed by physician

Comments: Do not use 25 mg Doxylamine (Vomex) in children under 12 years of age

Usual Pediatric Dose for Allergic Rhinitis

Doxylamine (Vomex) 5 mg oral tablet, chewable:

12 years or older: 10 mg orally every 4 to 6 hours not to exceed 6 doses daily

6 years to under 12 years: 5 mg orally every 4 to 6 hours not to exceed 6 doses daily

Usual Pediatric Dose for Allergic Conjunctivitis

Doxylamine (Vomex) 5 mg oral tablet, chewable:

12 years or older: 10 mg orally every 4 to 6 hours not to exceed 6 doses daily

6 years to under 12 years: 5 mg orally every 4 to 6 hours not to exceed 6 doses daily

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dialysis

Data not available

Usual Adult Dose for Megaloblastic Anemia

1 mg orally, intramuscularly, subcutaneously or IV once a day. May continue until clinical symptoms of folate deficiency and the hematological profile have normalized.

Usual Adult Dose for Folic Acid (Vomex) Deficiency

400 to 800 mcg orally, intramuscularly, subcutaneously or IV once a day.

Women of childbearing age, pregnant, and lactating women: 800 mcg orally, intramuscularly, subcutaneously or IV once a day.

Usual Pediatric Dose for Folic Acid (Vomex) Deficiency

Infant:

0.1 mg orally, intramuscularly, subcutaneously or IV once a day.

Child:

Less than 4 years: up to 0.3 mg orally, intramuscularly, subcutaneously or IV once a day.

4 years or older: 0.4 mg orally, intramuscularly, subcutaneously or IV once a day.

Usual Pediatric Dose for Vitamin/Mineral Supplementation

Recommended daily allowance (RDA):

Premature neonates: 50 mcg/day (15 mcg/kg/day).

Full-term neonates and infants 1 to 6 months: 25 to 35 mcg/day.

Children:

1 to 3 years: 150 mcg/day.

4 to 8 years: 200 mcg/day.

9 to 13 years: 300 mcg/day.

14 years and older: 400 mcg/day.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Rarely, a dosage of 2 mg/day may be required, particularly in patients with malabsorption, alcoholism, chronic hemolysis, chronic exfoliative skin disease or who are on concomitant anticonvulsant therapy.

Dialysis

Folic Acid (Vomex) is removed by both hemodialysis and peritoneal dialysis. The amount removed varies with type equipment used.

Because folate may accumulate in patients with end-stage renal disease, side effects may be more likely in this patient who is undergoing dialysis. Once this patient's body stores of folate are replete, three times a week dosing may be just as beneficial as once daily dosing but should portend a lower risk of side effects.

Other Comments

The recommended daily allowance of Folic Acid (Vomex) for adult males and females ranges from 150 to 200 and 150 to 180 mcg/day, respectively.

There is a potential danger in administering Folic Acid (Vomex) to patients with undiagnosed anemia, since Folic Acid (Vomex) may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress.

Severe megaloblastic anemia may require therapy for 4 to 5 weeks. Once stabilized, if dietary intake is inadequate, maintenance therapy can be started.

See also:
What is the most important information I should know about Doxylamine (Vomex)?

OTC labeling: Do not use in children <12 years of age.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to Doxylamine (Vomex) or any component of the formulation; narrow angle glaucoma; asthmatic attack; prostatic hypertrophy; stenosing peptic ulcer, pyloroduodenal obstruction; bladder-neck obstruction; concurrent use with monoamine oxidase-inhibitors.

See also:
What is the most important information I should know about Folic Acid (Vomex)?

Because it may mask the hematologic abnormalities while neurological damage progresses, Folic Acid (Vomex) should not be used in the therapy of patients with vitamin B12 deficiency of any cause, unless there is associated folate deficiency. The Folic Acid (Vomex) content of one tablet a day however, is unlikely to mask pernicious anemia should this condition be present. Also, pregnancy during pernicious anemia is very rare.

See also:
What is the most important information I should know about Vitamin B6 (Vomex)?

Contraindications for Vitamin B6 (Vomex) (Vitamin B6 (Vomex))

Vitamin B6 (Vomex) is contraindicated in those hypersensitive to any component of a Vitamin B6 (Vomex)-containing product.

Use Doxylamine (Vomex) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Doxylamine (Vomex) by mouth with or without food.
• Chew thoroughly before swallowing.
• Use Doxylamine (Vomex) exactly as directed on the package, unless instructed differently by your doctor. If you are taking Doxylamine (Vomex) without a prescription, follow any warnings and precautions on the label.
• If you miss a dose of Doxylamine (Vomex) and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Doxylamine (Vomex).

Use Folic Acid (Vomex) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Folic Acid (Vomex) may be administered as an injection by your health care professional.
• If you are using Folic Acid (Vomex) at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.
• If you miss a dose of Folic Acid (Vomex), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Folic Acid (Vomex).

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pyridoxine tablets are taken by mouth. Injectable pyridoxine is injected into a muscle or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

The recommended dietary allowance of pyridoxine increases with age. Follow your healthcare provider's instructions. You may also consult the Office of Dietary Supplements of the National Institutes of Health, or the U.S. Department of Agriculture (USDA) Nutrient Database (formerly "Recommended Daily Allowances") listings for more information.

Pyridoxine is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

Store at room temperature away from moisture and heat.

Use: Labeled Indications

Insomnia: Reduce difficulty falling asleep

Off Label Uses

Nausea and vomiting of pregnancy

Doxylamine (Vomex) is usually given in combination with pyridoxine for the treatment of nausea and vomiting of pregnancy. Data from a randomized placebo-controlled trial supports the use of Doxylamine (Vomex) and pyridoxine (Diclectin) in the treatment of nausea and vomiting of pregnancy.

Folic Acid (Vomex) is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells.

Folic Acid (Vomex) supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of Folic Acid (Vomex) either through their diet or supplements to prevent infant spinal cord birth defects.

How to use Folic Acid (Vomex)

Take this product by mouth with or without food as directed by your doctor, usually once daily. If you are taking the over-the-counter product, follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.

Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this product more often than directed.

Take this product regularly to get the most benefit from it. To help you remember, take it at the same time each day. Follow the diet plan recommended by your doctor or dietician. See also Notes section.

If your condition persists or worsens, or if you think you may have a serious medical problem, get medical help right away.

It is used for the treatment and prevention of Vitamin B6 (Vomex) deficiency. It is important for the breakdown of protein, fats, and carbohydrates from foods.

See also:
What other drugs will affect Doxylamine (Vomex)?

The simultaneous use of Doxylamine (Vomex) with psychotropic, anticonvulsant medications and ethanol is observed enhancement inhibitory action alprazolam on the CNS.

The simultaneous use with blockers of histamine H2-receptor reduce the clearance of alprazolam and increase the inhibitory effect of alprazolam on the CNS; macrolide antibiotics reduce the clearance of alprazolam.

The simultaneous use with hormonal oral contraceptives increased T1/2 of alprazolam.

Simultaneous administration of Doxylamine (Vomex) with dextropropoxyphene observed a more pronounced CNS depression than in combination with other benzodiazepines, as may increase the concentration of alprazolam in blood plasma.

Simultaneous treatment with digoxin increases the risk of intoxication by cardiac glycosides.

Alprazolam increases the concentration of imipramine in plasma.

Simultaneous administration with itraconazole, ketoconazole increases the effects of alprazolam.

Simultaneous administration with paroxetine may increases the effects of alprazolam due to the inhibition of its metabolism.

Fluvoxamine increases the concentration of alprazolam in plasma and risk of its side effects.

Simultaneous administration of Doxylamine (Vomex) with fluoxetine may increase the concentration of alprazolam in plasma by decreasing its metabolism and clearance under the influence of fluoxetine which is accompanied by psychomotor disorders.

It can not be exclude the possibility of strengthening effect of alprazolam for simultaneous administration with erythromycin.

See also:
What other drugs will affect Folic Acid (Vomex)?

Medications that interfere with your bodys ability to use folate may also increase the need for this vitamin. Medications can interfere with folate utilization, including: anticonvulsant medications (such as phenytoin, and primidone) metformin (sometimes prescribed to control blood sugar in type 2 diabetes) sulfasalazine (used to control inflammation associated with Crohns disease and ulcerative colitis) triamterene (a diuretic) Methotrexate There has been concern about the interaction between vitamin B12 and Folic Acid (Vomex). Folic Acid (Vomex) supplements can correct the anemia associated with vitamin B12 deficiency. Unfortunately, Folic Acid (Vomex) will not correct changes in the nervous system that result from vitamin B12 deficiency. Permanent nerve damage could theoretically occur if vitamin B12 deficiency is not treated. Therefore, intake of supplemental Folic Acid (Vomex) should not exceed 1000 micrograms (g, sometimes mcg) per day to prevent Folic Acid (Vomex) from masking symptoms of vitamin B12 deficiency. It is important for older adults to be aware of the relationship between Folic Acid (Vomex) and vitamin B12 because they are at greater risk of having a vitamin B12 deficiency. If you are 50 years of age or older, ask your physician to check your B12 status before you take a supplement that contains Folic Acid (Vomex).

See also:
What other drugs will affect Vitamin B6 (Vomex)?

Interactions for Vitamin B6 (Vomex) (Vitamin B6 (Vomex))

Amiodarone: Concomitant use of Vitamin B6 (Vomex) and amiodarone may enhance amiodarone-induced photosensitivity reactions. Doses of Vitamin B6 (Vomex) greater than 5-10 milligrams/day should be avoided by those taking amiodarone Carbamazepine: Chronic use of carbamazepine may result in a significant decrease in plasma pyridoxal 5-phosphate levels Cycloserine: Cycloserine may react with pyridoxal 5-phosphate to form a metabolically inactive oxime, which may result in a functional Vitamin B6 (Vomex) deficiency Ethionamide: The use of ethionamide may increase Vitamin B6 (Vomex) requirements Fosphenytoin: High doses of Vitamin B6 (Vomex) may lower plasma levels of phenytoin. Fosphenytoin is a prodrug of phenytoin Hydralazine: The use of hydralazine may increase Vitamin B6 (Vomex) requirements Isoniazid: (isonicotinic acid, INH). Isoniazid reacts with pyridoxal 5-phosphate to form a metabolically inactive hydrazone, which may result in functional Vitamin B6 (Vomex) deficiency Levodopa: Concomitant use of levodopa and Vitamin B6 (Vomex) in doses of 5 milligrams or more daily may reverse the therapeutic effects of levodopa. Vitamin B6 (Vomex) does not reverse the therapeutic effects of levodopa if levodopa is taken concurrently with the levodopa decarboxylase inhibitor carbidopa. Levodopa is typically administered as a combination product with carbidopa

Oral contraceptives: The use of oral contraceptives may increase Vitamin B6 (Vomex) requirements. This was more the case with the older oral contraceptive agents with high-dose estrogen/progestin. It appears to be less the case with the newer low-dose estrogen/progestin products Penicillamine: Penicillamine may react with pyridoxal 5-phosphate to form a metabolically inactive thiazolidine, which may result in a functional Vitamin B6 (Vomex) deficiency Phenelzine: Phenelzine may react with pyridoxal 5-phosphate to yield a metabolically inactive hydrazone compound Phenobarbital: High doses of Vitamin B6 (Vomex) may lower plasma levels of phenobarbital Phenytoin: High doses of Vitamin B6 (Vomex) may lower plasma levels of phenytoin Theophylline: Theophylline may react with pyridoxal 5-phosphate leading to low plasma levels of the coenzyme. This may increase the risk of theophylline-induced seizures Valproic acid: Chronic use of valproic acid may result in a significant decrease in plasma pyridoxal 5-phosphate levels.

See also:
What are the possible side effects of Doxylamine (Vomex)?

Undesirable effects reported for captopril and/or ACE inhibitor include:

Blood and lymphatic disorders:

Very Rare: neutropenia/agranulocytosis, pancytopenia particularly in patients with renal dysfunction, anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto-immune diseases and/or positive ANA-titres.

Metabolism and nutrition disorders:

Rare: Anorexia

Very Rare: Hyperkalaemia, hypoglycaemia

Psychiatric disorders:

Common: Sleep disorders.

Very Rare: Confusion, depression.

Nervous system disorders:

Common: Taste impairment, dizziness.

Rare: Drowsiness, headache and paraesthesia.

Very Rare: Cerebrovascular incidents, including stroke, and syncope.

Eye disorders:

Very Rare: Blurred vision.

Cardiac disorders:

Uncommon: Tachycardia or tachyarrhythmia, angina pectoris, palpitations.

Very Rare: Cardiac arrest, cardiogenic shock.

Vascular disorders

Uncommon: Hypotension, Raynaud syndrome, flush, pallor.

Respiratory, thoracic and mediastinal disorders:

Common: Dry, irritating (non productive) cough and dyspnoea.

Very Rare: Bronchospasm, rhinitis, allergic alveolitis / eosinophilic pneumonia.

Gastrointestinal disorders:

Common: Nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth.

Rare: Stomatitis/aphthous ulcerations.

Very Rare: Glossitis, peptic ulcer, pancreatitis.

Hepato-biliary disorders:

Very Rare: Impaired hepatic function and cholestasis. (including jaundice), hepatitis including necrosis, elevated liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders:

Common: Pruritus with or without a rash, rash and alopecia.

Uncommon: Angioedema

Very Rare: Urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions and exfoliative dermatitis.

Musculoskeletal, connective tissue and bone disorders:

Very rare: Myalgia, arthralgia.

Renal and urinary disorders:

Rare: Renal function disorders including renal failure, polyuria, oliguria, increased urine frequency.

Very Rare: Nephrotic syndrome.

Reproductive system and breast disorders:

Very Rare: Impotence, gynaecomastia.

General disorders:

Uncommon: Chest pain, fatigue, malaise.

Very Rare: Fever

Investigations:

Very Rare: Proteinuria, eosinophilia, increase of serum potassium, decrease of serum sodium, elevation of BUN, serum creatinine and serum bilirubin, decreases in haemoglobin, haematocrit, leucocytes, thrombocytes, positive ANAtitre, elevated ESR.

Intestinal angioedema has also been reported very rarely in patients with ACE inhibitors and should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

See also:
What are the possible side effects of Folic Acid (Vomex)?

Allergic sensitization has been reported following both oral and parenteral administration of Folic Acid (Vomex).

Folic Acid (Vomex) is relatively nontoxic in man. Rare instances of allergic responses to Folic Acid (Vomex) preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg Folic Acid (Vomex) daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B12 serum levels may occur in patients receiving prolonged Folic Acid (Vomex) therapy.

In an uncontrolled study, orally administered Folic Acid (Vomex) was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of Folic Acid (Vomex) daily.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 844-740-7500.

See also:
What are the possible side effects of Vitamin B6 (Vomex)?

Applies to pyridoxine: capsule, injectable, solution, tablet, tablet enteric coated, tablet extended release

As well as its needed effects, pyridoxine (the active ingredient contained in Vitamin B6 (Vomex)) may cause unwanted side effects that require medical attention.

Severity: Moderate

If any of the following side effects occur while taking pyridoxine, check with your doctor or nurse as soon as possible:

With large doses

• Clumsiness
• numbness of hands or feet