Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 14.05.2022
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Betaine (Multi-Zyme)® (Betaine (Multi-Zyme) anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are:
- Cystathionine beta-synthase (CBS) deficiency
- 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
- Cobalamin cofactor metabolism (cbl) defect
They are used as an adjunct in the treatment of soft-tissue inflammation and oedema associated with trauma and surgery. Bromelains are a concentrate of proteolytic enzymes derived from the pineapple plant, Ananas comosus (A. sativus) (Bromeliaceae). and used in the treatment of partial deep dermal and full thickness burns.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Adjunctive therapy of dyspeptic disorders
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.liver, bile, and pancreas disorders
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Papain (Multi-Zyme) consists chiefly of a mixture of Papain (Multi-Zyme) and chymopapain, proteolytic enzymes that hydrolyse polypeptides, amides, and esters, especially at bonds involving basic amino acids, or leucine or glycine, yielding peptides of lower molecular weight. It is used with urea as a topical debriding agent. It is also used for the removal of protein deposits from the surface of soft contact lenses ().
Preparations of Papain (Multi-Zyme), alone or combined with antibacterial agents and/or other substances, have been taken by mouth for their supposed anti-inflammatory properties, and it has also been used as an ingredient of various mixtures claimed to aid digestion.
Papain (Multi-Zyme) is widely used as a meat tenderiser and in the clarification of beverages.
Malignant neoplasms.
Papain (Multi-Zyme) has been included in proteolytic enzyme preparations used in oncology to reduce the adverse effects of chemotherapy and radiotherapy. Although the number of clinical studies on which to judge efficacy is limited, a review1 of such studies suggested that systemic enzyme therapy might be beneficial. Clinical studies have used a preparation containing Papain (Multi-Zyme), trypsin, and chymotrypsin in a weight ratio of 5:2:2, and the beneficial effect seems to be based on its anti-inflammatory potential.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.dyspepsia without hyperacidity, oral vehicle
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.In combination w/ other antiretrovirals for the treatment of HIV-1 infected patients.
Betaine (Multi-Zyme) is a nutrient that is important for functioning of the heart and blood vessels. Betaine (Multi-Zyme) works in the body by preventing the build-up of an amino acid called homocysteine. This amino acid can harm blood vessels and contribute to heart disease, stroke, or circulation problems.
Betaine (Multi-Zyme) is a byproduct of sugar beet processing.
Betaine (Multi-Zyme) is used to reduce homocysteine levels in people with a genetic condition called homocystinuria, in which the amino acid builds up in the body. Betaine (Multi-Zyme) is not a cure for homocysteinuria.
Betaine (Multi-Zyme) may also be used for purposes not listed in this medication guide.
Dosage
The usual dosage in adult and pediatric patients is 6 grams per day administered orally in divided doses of 3 grams twice daily. In pediatric patients less than 3 years of age, dosage may be started at 100 mg/kg/day divided in twice daily doses, and then increased weekly by 50 mg/kg increments.
Therapy with Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) should be directed by physicians knowledgeable in the management of patients with homocystinuria. Patient response to Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) can be monitored by homocysteine plasma levels. Dosage in all patients can be gradually increased until plasma total homocysteine is undetectable or present only in small amounts. Response (by homocysteine plasma levels) usually occurs within several days and steady state within a month. Plasma methionine concentrations should be monitored in patients with CBS deficiency.
Dosages of up to 20 grams per day have been necessary to control homocysteine levels in some patients. However, one pharmacokinetic and pharmacodynamic in vitro simulation study indicated minimal benefit from exceeding a twice-daily dosing schedule and a 150 mg/kg/day dosage for Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous).
Administration
The prescribed amount of Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) should be measured with the measuring scoop provided (one level 1.7 mL scoop is equal to 1 gram of Betaine (Multi-Zyme) anhydrous powder) and then dissolved in 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula, or mixed with food for immediate ingestion.
How supplied
Dosage Forms And Strengths
Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) is a white, granular, hygroscopic powder for oral solution available in bottles containing 180 grams of Betaine (Multi-Zyme) anhydrous.
Storage And Handling
Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) is available in plastic bottles containing 180 grams of Betaine (Multi-Zyme) anhydrous. Each bottle is equipped with a plastic child-resistant cap and is supplied with a polystyrene measuring scoop. One level scoop (1.7 mL) is equal to 1 gram of Betaine (Multi-Zyme) anhydrous powder.
NDC 66621-4000-1 180 g/bottle
Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) can be ordered by calling Accredo Health Group, Inc., Customer service at 1-888-454-8860
Storage
Store at room temperature, 15 – 30 °C (59 – 86 °F). Protect from moisture.
Distributed in the U.S. by: Rare Disease Therapeutics, Inc. 2550 Meridian Blvd., Suite 150 Franklin, TN 37067.
Adult & childn ≥12 yr 1-2 cap bd.
Chew or suck 2 tab qds for the 1st day, then 1 tab qds for at least 5 days.
See also:
What is the most important information I should know about Betaine (Multi-Zyme)?
You should not use Betaine (Multi-Zyme) if you are allergic to it.
To make sure you can safely take Betaine (Multi-Zyme), tell your doctor about all of your medical conditions.
Follow the directions on your prescription label. Do not use in larger or smaller amounts or for longer than recommended. Your doctor may occasionally change your dose to make sure you get the best results.
Betaine (Multi-Zyme) must be mixed with water, juice, milk, food or infant formula just before taking it.
Stop using Betaine (Multi-Zyme) and call your doctor at once if you have an unusual headache, dizziness, neck pain or stiffness, problems with memory or speech, changes in your mental state, vision changes, decreased consciousness, or seizure (black-out or convulsions).
Betaine (Multi-Zyme) is only part of a complete program of treatment that may also include other vitamin and mineral supplements and a special diet. Follow your diet and medication routines very closely.
Hypersensitivity to any component.
Due to the presence of sucrose, this drug is contraindicated in cases of fructose intolerance, malabsorption glucose and galactose or sucrase-isomaltase.
Due to the presence of lactose, this drug is contraindicated for galactosemia congenital malabsorption of glucose and galactose or lactase deficiency.
none known
Patients w/ generalised or systemic infections or w/ disorders of blood coagulation.
Readministration to patients w/ history of hypersensitivity to the drug. Severe hepatic impairment or pre-treatment ASAT or ALAT >5 ULN. Lactation.
Use Betaine (Multi-Zyme) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Betaine (Multi-Zyme) by mouth with or without food.
- Shake the bottle gently before removing the cap.
- Use the scoop that comes with Betaine (Multi-Zyme) to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Mix the prescribed amount of medicine with 4 to 6 ounces of water, juice, milk, or formula until it is completely dissolved. You may also mix Betaine (Multi-Zyme) with food. Swallow the mixture right away.
- Replace the cap tightly after each dose.
- If you miss a dose of Betaine (Multi-Zyme), 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 Betaine (Multi-Zyme).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Bromelain (Multi-Zyme) is used for reducing swelling (inflammation) after surgery or injury, especially of the nose and sinuses. It is also used for hay fever, treating a bowel condition that includes swelling and ulcers (ulcerative colitis), removing dead and damaged tissue after a burn (debridement), preventing the collection of water in the lung (pulmonary edema), relaxing muscles, stimulating muscle contractions, slowing clotting, improving the absorption of antibiotics, preventing cancer, shortening labor, and helping the body to get rid of fat.
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What other drugs will affect Betaine (Multi-Zyme)?
The sedative effect of this medicine will be increased if it is taken with any of the following, which can also cause drowsiness:
* alcohol
* antipsychotics, eg chlorpromazine, haloperidol
* baclofen
* barbiturates, eg phenobarbital, amobarbital
* benzodiazepines, eg diazepam, temazepam
* MAOI antidepressants, eg phenelzine
* other sleeping tablets, eg zopiclone
* sedating antihistamines, eg chlorphenamine, hydroxyzine, promethazine
* strong opioid painkillers, eg morphine, codeine
* tricyclic and related antidepressants eg amitriptyline, maprotiline.
This medicine may increase the anti-blood-clotting effects of oral anticoagulant medicines such as warfarin. If you are taking warfarin your doctor may want to check your blood-clotting time (INR) after you start and stop treatment with this medicine.
If a furosemide injection is administered to someone who has taken this medicine, it may cause sweating, hot flushes and changes in blood pressure due to a hypermetabolic state caused by an effect on thyroid hormone.
May increase antibiotic action; risk of bleeding w/ anticoagulants & antiplatelets.
No spesific interactions
none known
Anti-coagulants.
Drugs extensively metabolised by CYP3A or CYP2B6. Ketoconazole, fluconazole, warfarin, rifampicin, rifabutin, methadone, OCs, clarithromycin, cimetidine
See also:
What are the possible side effects of Betaine (Multi-Zyme)?
Adverse Reactions in Clinical Studies
The most serious adverse reaction reported with Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) treatment is the development of hypermethioninemia and cerebral edema in patients with CBS Deficiency.
The assessment of clinical adverse reactions is based on a survey study of 41 physicians, who treated a total of 111 homocystinuria patients with Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous). Adverse reactions were retrospectively recalled and were not collected systematically in this open-label, uncontrolled, physician survey. Thus, this list may not encompass all types of potential adverse reactions, reliably estimate their frequency, or establish a causal relationship to drug exposure. The following adverse reactions were reported (Table 1):
Table 1: Number of Patients with Adverse Reactions to Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) by Physician Survey
| Adverse Reactions | Number of Patients |
| Nausea | 2 |
| Gastrointestinal distress | 2 |
| Diarrhea | 1 |
| “Bad taste” | 1 |
| “Caused odor” | 1 |
| Questionable psychological changes | 1 |
| “Aspirated the powder” | 1 |
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In postmarketing experience with Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous), severe cerebral edema and hypermethioninemia have been reported within 2 weeks to 6 months of starting Betaine (Multi-Zyme) therapy, with complete recovery after discontinuation of Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous). All patients who developed cerebral edema had homocystinuria due to CBS deficiency and had severe elevation in plasma methionine levels (range 1,000 to 3,000 μM). As cerebral edema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to Betaine (Multi-Zyme) therapy has been postulated as a possible mechanism of action.
The following adverse reactions have been reported in patients during postmarketing use of Betaine (Multi-Zyme) (Betaine (Multi-Zyme) anhydrous) : anorexia, agitation, depression, irritability, personality disorder, sleep disturbed, dental disorders, diarrhea, glossitis, nausea, stomach discomfort, vomiting, hair loss, hives, skin odor abnormalities, and urinary incontinence.
Bromelains may cause nausea, vomiting, and diarrhoea. Metrorrhagia and menorrhagia have occasionally occurred. Hypersensitivity reactions have been reported and have included skin reactions and asthma.
No informations
none known
Hypersensitivity reactions have occurred.
Effects on the eyes.
Ocular and periorbital angioedema occurring within 4 hours of use of a contact lens cleansing solution containing Papain (Multi-Zyme) has been reported.1
Extensive destruction of the oesophageal wall, with perforation, resulted from the use of a Papain (Multi-Zyme) suspension given to treat an obstruction caused by impacted meat.1 The patient had been given 1.2 g of Papain (Multi-Zyme) over a 12-hour period. Ten days after a thoracotomy, the descending thoracic aorta ruptured, and she died from haemorrhage.
Rash, allergic reactions, hepatitis, abnormal liver function tests, nausea, vomiting, diarrhoea, abdominal pain, fatigue, fever, headache & myalgia.
Bromelain (Multi-Zyme), a naturally occurring phytoenzyme is present in pineapple and pineapple juice. Bromelain (Multi-Zyme) is generally prescribed for the treatment of osteoarthritis, inflammation, hay fever, ulcerative colitis, debridement and shortening of labor. Bromelain (Multi-Zyme) can help muscle relaxation, improve antibiotic absorption and prevent cancer.
Bromelain (Multi-Zyme) is generally available as Bromelain (Multi-Zyme) with trypsin and rutin formulations.
Diastase + Pepsin (Multi-Zyme) is indicated as a digestive aid and for the treatment of acid indigestion, sour stomach, flatulence, epigastric distress, dyspepsia, eructation and to increase appetite.