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Monoloc Tablet

Generic Name(s): Ranitidine

Why it's used

Monoloc Tablet is used for the short-term treatment and maintenance after healing of stomach ulcers. This medicine works by reducing the amount of acid in the stomach. This medicine helps by relieving the symptoms of indigestion and heartburn. Monoloc is also used to treat a hypersecretory condition in which the stomach produces more amount of acid (Zollinger-Ellison syndrome and systemic mastocytosis), for the short-term treatment and maintenance after healing of stomach ulcers (active and benign), to treat the symptoms of backflow of stomach acid into the food pipe (gastroesophageal reflux disease), to treat the inflammation of food pipe and maintenance of healing of inflamed food pipe, to prevent stomach ulcers associated with NSAIDs, treat stomach ulcers due to bacterial infection, post-operative conditions, and digestive disease where stomach acid irritates the food pipe, to prevent digestive tract bleeding due to stress ulceration in ill patients, to prevent repetitive bleeding with bleeding stomach ulcers, to prevent the risk of aspiration of stomach contents during pregnancy before giving anesthesia, and to treat the symptoms of backflow of stomach acid into the food pipe and food pipe inflammation in children.
Monoloc Tablet may also be used together with other medicines to treat certain conditions as recommended by the doctor. It is used in combination with Antacids to relieve pain in patients with active or less harmful stomach ulcers, a condition in which stomach produces more amount of acid, and food pipe inflammation.
Histamine-2 Receptor Antagonist
Monoloc is a prescription medicine that belongs to a class of medicines called Histamine-2 Receptor Antagonist. Histamine2 receptor antagonists are a class of medications used in the treatment of indigestion, gastric ulcers, and gastroesophageal reflux disease. These medicines decrease the production of stomach acid.

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How to use

Read the directions on the product label, patient guide, or medicine guide provided by the medicine company or your pharmacist before starting to use Monoloc Tablet. If you have any questions related to this medicine, ask your doctor or pharmacist. Use this medicine as recommended by your doctor.
Monoloc Tablet is used with or after food. In the case of a stomach ulcer, it is not necessary to adjust the dose in relation to meals. Monoloc syrup can also be given to patients in the evening or at bedtime in whom dosing convenience is necessary. Monoloc Tablet is used usually at bedtime.

Typical Dosage

The typical dose of Monoloc is 150 mg/10 ml of syrup twice daily and 300 mg/20 ml of syrup once a day in the evening or at bedtime. The usual dose for children is 2-4 mg/kg (0.9-1.81 mg/lb) twice a day up to a maximum dose of 300 mg once a day. The maximum adult dose of Monoloc is 300 mg in a day. This medicine is typically used for a period of 4 weeks for stomach ulcers, 4-8 weeks for stomach ulcers associated with NSAIDs treatment, 2 weeks for the digestive disorder (gastroesophageal reflux disease, GERD), and 8-12 weeks for inflammation of food pipe (oesophagitis). This medicine is not known to be habit-forming.
This medicine should be used on an as-needed basis. Typically in patients with healed inflammation of food pipe, long-term treatment is given at the dose of 150 mg twice a daily.
If using the effervescent form of this medicine, dissolve the prescribed number of tablets in water or the solution indicated on the medicine. After the tablets are fully dissolved, drink the solution right away. Do not consume the medicine long after it has been dissolved in water.
Monoloc injection is intended for use into the veins and deep in the muscles use only. Injection into the veins can be given as a rapid dose (bolus) as well as a continuous infusion. Monoloc injection premixed in plastic containers is to be taken by slow injection as an infusion into the veins (intravenous) only.
If using the liquid form of this medicine, measure the dose using the provided measuring cup, spoon, or dropper. Before pouring the medicine into the measuring device, you should check the measurement markings carefully. Then, pour the dose amount into the device. After use, clean and store the measuring device in a safe place for your next use. You should not use a tablespoon or teaspoon as the dose measuring devices since it can result in an incorrect dose. If indicated on the product package, shake the medicine before use.

Talk to Your Doctor

Talk to your doctor if you develop new symptoms. Tell your doctor if stomach or intestine ulcer, difficulty to swallow, stomach pain, weight loss without trying, and rare blood disease (porphyria). If you have any kidney disease, a dosage of 150 mg/10 ml of syrup is recommended every 24 hours in patients with abnormal functioning of kidneys, it can further be changed depending upon patient's condition. If you have issues with the health of your liver, caution should be observed in patients with liver dysfunction because the breakdown of Monoloc occurs in the liver.
Your doctor may recommend a lower initial dose of this medicine to see the impact of this medicine on the body. Please follow your doctor's directions. Older patients may see an increase in the incidence of side-effects with this medicine. As a result, a lower dose may be recommended for older patients.

Use in Children

If you are giving Monoloc Tablet to a child, be sure to use a product that is meant for children. Before giving this medicine to a child, use the child's weight or age to find the right dose from the product package. You can also read the dosage section of this page to know the correct dose for your child. Else, consult with your doctor and follow their recommendation.

Avoid Alcohol

Avoid the consumption of alcohol with Monoloc.

Storage

You should store Monoloc Tablet 2°C - 30°C (36°F - 86°F), away from moisture, and away from light. Store the medicine away from the reach of children and pets.
Medicines may be prescribed for uses other than those listed in the medicine guide. Do not use Monoloc Tablet for conditions for which it was not prescribed. Do not give Monoloc Tablet to other people who might have the same conditions or symptoms that you have. Self-medication may harm them.

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How to take Monoloc

The dose and frequency of using Monoloc will depend on the following factors:
  • age of the patient
  • the weight of the patient
  • patient's health
  • the health of the patient's liver
  • the health of the patient's kidneys
  • medicines recommended by the doctor
  • any other medicines being used
  • herbal supplements being used

Monoloc Dosage

Dosage for active duodenal ulcer

Adult
  • Recommended: 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg) twice daily
Children (1 month to 16 years)
  • Recommended: 2 to 4 mg/kg or 0.9 to 1.82 mg/lb/kg twice daily
  • Maximum: 300 mg/day

Dosage for maintenance of healing of duodenal ulcers

Adult
  • Recommended: 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of Monoloc) at bedtime.
Children (1 month to 16 years)
  • Recommended: 2 to 4 mg/kg or 0.9 to 1.82 mg/lb/kg once daily
  • Maximum: 150 mg/day

Dosage for abnormally increased acid production

Adult
  • Recommended: 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of Monoloc) twice a day. Dosages should be adjusted according to an individual patient's needs and therefore should be continued as long as clinically advisable. Dosages up to 6 g/day have been used in patients with severe disease

Dosage for benign stomach ulcer

Adult
  • Recommended: 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of Monoloc) twice a day.

Dosage for maintenance of healing of gastric ulcers

Adult
  • Recommended: 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of Monoloc) at bedtime
Children (1 month to 16 years)
  • Recommended: 2 to 4 mg/kg or 0.90 to 1.81 mg/lb/kg once daily
  • Maximum: 150 mg/day

Dosage for gastroesophageal reflux disease (GERD)

Adult
  • Recommended: 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of Monoloc) twice a day
Children (1 month to 16 years)
  • Recommended: 5 to 10 mg/kg or 2.27 to 4.54 mg/lb/kg once a day, usually given as 2 divided doses

Dosage for inflammation of food pipe (erosive esophagitis)

Adult
  • Recommended: 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of Monoloc) 4 times a day
Children (1 month to 16 years)
  • Recommended: 5 to 10 mg/kg or 2.27 to 4.54 mg/lb/kg once a day, usually given as 2 divided doses

Dosage for maintenance of healing of erosive esophagitis

Adult
  • Recommended: 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of Monoloc) twice a day.

Dosage for long-term episodic indigestion (dyspepsia)

Adult
  • Recommended: 150 mg twice daily for six weeks

Dosage for prevention of recurrent bleeding or ulceration bleeding

Adult
  • Recommended: 150 mg twice daily

Dosage for prevention of lung disease (Mendelson's syndrome)

Adult
  • Recommended: 150 mg should be taken 2 hours before giving general anesthesia, and 150 mg the previous evening, In pregnant patients at beginning of labour, a dose of 150 mg may be given which is followed by 150 mg at an interval of six hours.

Dosage for esophageal reflux disease

Adult
  • Recommended: 150 mg twice daily or 300 mg during bedtime for 8 weeks or if necessary 12 weeks.
  • Maximum: Patients with moderate to severe esophagitis, the dose for Monoloc may be increased to 150 mg daily four times up to 12 weeks.

Dosage for stomach ulcers

Children (1 month to 16 years)
  • Recommended: 2 to 4 mg/kg 0.90 to 1.82 mg/lb/kg twice daily
  • Maximum: 300 mg/day

Minimum Age

1 month

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Tablet
Strength: 150 mg, 300 mg, and 400 mg
Effervescent tablet
Strength: 20 mg, 25mg and 150 mg
Injection
Strength: 25 mg/mL and 50 mg/50 mL
Liquid
Strength: 25 mg
Syrup
Strength: 15 mg/1ml
Capsule
Strength: 150 mg and 300 mg
Solution
Strength: 15 mg, 15 mg/1ml, 50 mg, 75 mg, 75mg/5ml, and 150 mg/1ml

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued. Avoid taking a double dose to make up for a missed one.

Overdose

What to do if you overdose on Monoloc?
If you have taken more than the recommended dose of Monoloc, unabsorbed material from the gastrointestinal tract should be removed. Also, supportive therapy and clinical monitoring should be done.
Symptoms of an overdose of Monoloc
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Monoloc Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Monoloc

Before you use Monoloc, tell your doctor of your medical and health history including the following:
  • a birth defect due to building up of amino acid in the body (phenylketonuria)
  • group of disorders that affect the nervous system (acute porphyria)
  • high blood sugar
  • kidney disease
  • liver disease
  • long-term lung disease
  • stomach ulcer
Since the breakdown of Monoloc occurs in liver, caution should be observed in patients with liver dysfunction. Patients with the history of a group of disorders that affect the nervous system (acute porphyria) may experience the worsening of the condition, therefore the use of this medicine in such patients should be avoided.
Before you use Monoloc Tablet, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information.
The use of this medicine may change liver enzyme (SGPT). Monoloc increases liver enzyme (SGPT) when given at greater than recommended dose in injection form. Patients who are on treatment with Monoloc intravenous injection at a dose of ≥100 mg 4 times a day for a period of 5 days should monitor SGPT levels daily.
The use of Monoloc Tablet may change creatinine level. Monoloc may cause an increase in creatinine level.

Alcohol

Avoid the consumption of alcohol with Monoloc Tablet.

Use in Pregnancy

Monoloc Tablet should be used in pregnancy only when required. Monoloc is known to cross the placenta and Monoloc should only be used if it is found to be important during pregnancy.

Use while Breastfeeding

Monoloc should be used while breastfeeding only when required. Monoloc may pass into breast milk so caution should be taken.

Impact on Fertility

It is not known if this medicine is safe for use in women who are conceiving. Consult with your doctor before you use Monoloc Tablet. No data has been reported regarding fertility.

Dizziness

Monoloc Tablet can make you feel sleepy. Be careful while driving, using machinery, or doing any other activity that needs you to be alert. The consumption of alcohol with Monoloc Tablet can make you feel more sleepy.

Side-effects in Older Patients

Monoloc Tablet may increase side-effects in older patients. Elderly patients may see an increased risk of a feeling of discomfort, persistent problems in staying and falling asleep (insomnia), sleepiness, dizziness, vertigo, mental confusion, agitation, depression, hallucinations, blurred vision, and movement disturbances (involuntary motor disturbances).

What precautions should be taken during Pregnancy and Nursing, and administering Monoloc to Children or the Older Adults?

Pregnant Women

Only When Necessary
Warning: Monoloc should be used in pregnancy only if clearly needed.

Breastfeeding

Precaution
Warning: Caution should be taken while taking Monoloc as it may pass into breast milk.

Younger Adults Population

Possibly safe
Warning: Effectiveness and safety in neonates (less than one month) has not been confirmed.

Older Adults Population

Management or monitoring precaution
Warning: Dosage for the patient with kidney disease should be adjusted since elderly patients are at an increased risk to experience the harmful effects due to reduced functioning of kidneys.

Monoloc Side-effects

The following side-effects may commonly occur in older patients on the use of Monoloc Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Monoloc Tablet may cause the following side-effects:
The following severe side-effects may also occur when using Monoloc Tablet:
  • Heart disorders
    Symptoms: increased heartbeat, decreased heartbeat, cardiac electrical disorder (atrioventricular block) extra heartbeats in the lower chamber of the heart (premature ventricular beats)
    Patients should stop taking Monoloc tablets and consult a doctor right away.
  • Liver disorders such as stoppage of the bile flow (cholestatic), hepatocellular, or mixed hepatitis with or without jaundice (possibly fatal)
    Symptoms: liver failure increased liver enzyme (SGPT) level
    The medicine should be immediately discontinued.
  • Skin and its appendages disorders
    Symptoms: rash, severe skin reaction (erythema multiforme) inflammation of the blood vessels (vasculitis)
    Patients should stop taking Monoloc tablets and consult a doctor right away.
  • Kidney disorder
    Symptoms: swelling in between the kidney tubules (acute interstitial nephritis)
    The patient should stop taking Monoloc tablets and consult a doctor right away.
  • Central nervous system disorders
    Symptoms: mental confusion, nervousness (agitation), depression hallucination
  • Gastrointestinal disorders
    Symptoms: constipation, diarrhea, vomiting inflammation in the pancreas (acute pancreatitis)
    Patients should stop taking Monoloc tablets and consult a doctor right away.
  • Hematologic disorders
    Symptoms: decrease in white blood cells (leukopenia), decreased granulocytes (granulocytopenia), abnormally low levels of thrombocytes, deficiency of red cells, white cells, and platelets (pancytopenia) anemia (aplastic or hemolytic)
  • Immune system disorders
    Symptoms: difficulty in breathing (bronchospasm), fever, severe allergic reaction (anaphylaxis), increase in blood creatinine, low blood pressure shortness of breath (dyspnea)
    Patients should stop taking Monoloc tablets and consult a doctor right away.
Your doctor has prescribed Monoloc Tablet because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Monoloc Tablet.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Monoloc by Severity and Frequency

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:
Patients should stop taking Monoloc tablets and consult a doctor right away.

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
Patients should stop taking Monoloc tablets and consult a doctor right away.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Fructose Intolerance

Patients with a family history of fructose intolerance should not take this medicine as Monoloc oral solution contains sorbitol.

Alcoholism

Pregnant or lactating women and patients who are suffering from alcoholism, liver disease, seizures (epilepsy), brain injury or disease may suffer from harmful effects. Alcohol in Monoloc oral solution may change the effect of other medicines. It may also affect the ability of a person to drive or use machinery. Alternative formulations of Monoloc may be considered in such patients.

Monoloc Oral Solution Contains Sodium

Patients who are on a controlled diet containing sodium, care should be taken while taking the oral solution.

Hide the Signs of Cancer

Patients with a stomach ulcer, new or recently changed indigestion symptoms, and middle-aged people are at an increased risk when using this medicine. Treatment with Monoloc may hide the symptoms of stomach cancer in such patients. The possibility of cancer should be eliminated before starting treatment with Monoloc.

Kidney Dysfunction

Patients with kidney dysfunction are at an increased risk for high levels of Monoloc in blood. Dosage adjustment of Monoloc should be done in patients with kidney dysfunction.

Blood Disorder

Patients with a history of blood disorder affecting the nervous system (acute porphyria) are at an increased risk when using this medicine. Such patients may cause sudden and fast attacks of porphyria. Monoloc should not be used in such patients.

Risk of Community-Acquired Pneumonia

Elderly patients, patients with long-term lung disease, high blood sugar or have a dysfunctional immune system are at an increased risk to develop this disease. Monoloc causes reversible mental confusion, depression, and hallucinations in severely ill and elderly patients as well as increases the risk of community-acquired pneumonia.

Patients on Treatment with NSAIDs

Elderly patients and patients with a history of stomach ulcers are at risk when taking these medicines. The patients who are on treatment with both NSAIDs and Monoloc should be regularly supervised.

Interactions with Monoloc

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Monoloc Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Gefitinib

Your doctor's guidelines may need to be followed while taking this medicine along with gefitinib, which is used in cancer treatment. Gefitinib absorption was reduced by 44% when taken with Monoloc and sodium bicarbonate. The patient should be cautious while taking this medicine.

Warfarin

Monoloc Tablet interacts with warfarin, which is used to prevent blood clots. When Monoloc is used with warfarin, increased or decreased time taken by blood to clot (prothrombin time) has been reported in patients. Close monitoring of change in prothrombin time is recommended in patients who are on treatment along with Monoloc.

Procainamide

There may be an interaction of Monoloc with procainamide and N-acetylprocainamide, which are used to treat irregular heartbeat. High doses of Monoloc may reduce the excretion of procainamide and N-acetylprocainamide from the kidneys and may lead to increased levels of these drugs in the blood. Patients should monitor the damage due to procainamide if Monoloc dose is more than 300mg for a day.

Cytochrome P-450 Enzymes

Monoloc Tablet may interact with cytochrome P-450 enzymes, which are important for the metabolism of different medicines. Interaction of Monoloc and cytochrome P-450 may change the bioavailability of certain drugs. At recommended doses, Monoloc does not prevent the action of cytochrome P-450 enzymes in the liver. Monoloc at usual therapeutic doses does not increase the actions of drugs which are inactivated by P-450 enzyme systems such as lidocaine, diazepam, propranolol, phenytoin, and theophylline.

Atazanavir and Delavirdine

Special instructions need to be followed while taking this medicine along with atazanavir and delavirdine, which are used to treat HIV/AIDS. Monoloc affects the pH of the stomach which may change the absorption of atazanavir and delavirdine. Patients should use atazanavir with caution and also see its label for proper recommendation. Long-term use of delavirdine is not recommended with Monoloc.

Midazolam

Your doctor's guidelines may need to be followed while taking this medicine along with midazolam, which is used to cause drowsiness, decrease anxiety, and to decrease the memory of the surgery or procedure. when midazolam is used with Monoloc, it increases the absorption of midazolam. Monitoring of the patients should be done for excessive sedation when Monoloc is taken with oral midazolam.

Triazolam

Monoloc Tablet interacts with triazolam, which is used as a central nervous system depressant. Levels of triazolam in blood are higher during twice-daily dosing of Monoloc as compared to when triazolam is given alone. Monitoring of patients for prolonged sedation is required.

Sucralfate

Special instructions need to be followed while taking this medicine along with sucralfate, which is used to treat stomach ulcers. When Monoloc is used with sucralfate, the absorption of Monoloc is reduced. Patient must take sucralfate at least two hours after Monoloc.

Ketoconazole

There may be an interaction of Monoloc with ketoconazole, which is used to treat fungal infections. Ketoconazole absorption was reduced by up to 95% when given together with an oral dose of Monoloc.

Glipizide

Monoloc Tablet may interact with glipizide, which is used to treat high blood sugar (diabetes). Monoloc at single 150 mg dose increases the absorption of glipizide by 34%. Appropriate clinical monitoring should be done while starting or stopping Monoloc.

Interactions of Monoloc by Severity

Severe

The following medicines are usually not to be taken together without consulting with your doctor or pharmacist.

Serious

The following medicines may interact when taken together and can cause harmful effects in the body. Please consult with your doctor or pharmacist before taking these medicines together.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Monoloc be not used?

Severe Allergic Reactions

This medicine is not used in patients with severe allergic reactions to Monoloc.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Monoloc is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Monoloc Tablet .
Stomach Disorders
Zollinger Ellison syndrome
Peptic Ulcer
Digestive Diseases

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