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NAPROSYN D 250MG TAB

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NAPROSYN D 250MG TAB
Naprosyn D Tablet 250mg
Uses and Benefits

Uses and Benefits

Naprosyn D Tablet 250mg is a nonsteroidal anti-inflammatory medicine (NSAID) used in the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, juvenile idiopathic arthritis, dysmenorrhea, mild to moderate pain. It is also used to treat acute musculoskeletal disorders and acute gout. Besides, it helps to treat nausea, vomiting and gastrointestinal motility disorders upto some extent. However, the uses mentioned here are not exhaustive. There may be other conditions for which this medication may be used upon a doctor’s discretion.

Composition

Composition

The active ingredients of Naprosyn D Tablet 250mg are Domperidone 10mg and Naproxen 250mg.

Mechanism of Action of Drugs

Mechanism of Action of Naproxen:

Domperidone possesses anti-emetic properties which help reduce vomiting and vomiting sensation; and also treats gastric problems to an extent.

Naproxen possesses NSAID properties. Therefore, the drug helps in reducing the synthesis of prostaglandins that causes pain and inflammation.

Contraindications and Cautions

Contraindications and Caution

Patients with the following conditions are suggested to seek advice from their health care professionals before taking the Naprosyn D Tablet 250mg:

  • Hypersensitivity to any of the ingredients used in the Naprosyn D Tablet 250mg such as Domperidone and Naproxen
  • Asa or NSAID induced asthma or urticaria
  • Aspirin triad
  • Prolactin releasing pitutary tumor
  • QT prolongation
  • Electrolyte disturbance
  • Cardiac disease
  • GI hemorrhage
  • Mechanical obsruction or perforation
  • Moderate to severe hepatic impairment
  • Caution:
  • Recent MI
  • Cardiovascular disease
  • Cardiac disease risk
  • HTN
  • CHF
  • Fluid retention
  • Dehydration
  • PUD
  • GI bleeding history
  • Coagulation disorder
  • Hepatic impairment
  • Renal impairment
  • Asthma
  • Sodium restriction
  • Debilitated patients
Side Effects

Side and Adverse Effects

The following side effects may or may not occur during the usage of this Naprosyn D Tablet 250mg. It is generally well tolerated when taken in the prescribed dosage guidelines. More common ones are generally mild and may include:

  • Dyspepsia
  • Nausea
  • Abdominal pain
  • Constipation
  • Dizziness
  • Headache
  • Drowsiness
  • Rash
  • ALT, AST elevated
  • Fluid retention
  • Tinnitus
  • Ecchymosis
  • Dyspnea
  • Photosensitivity
  • Delayed ovulation
  • Dry mouth
  • Increased prolactin levels
  • Amenorrhea
  • Gynaecomastia
  • Breast pain and tenderness
  • Convulsions
  • Dystonic reactions
  • Urticaria
  • Rash
  • Pruritus
  • Transient intestinal cramps
  • Diarrhea
  • Nervousness

Rare but more serious adverse effects may include:

  • GI bleeding
  • GI perforation ulcer
  • MI
  • Stroke
  • Thromboembolism
  • HTN
  • CHF
  • Renal papillary necrosis
  • Nephrotoxicity
  • Hepatotoxicity
  • Anaphylaxis/anaphylactoid reaction
  • Bronchospasm
  • Exfoliative dermatitis
  • Stevens-johnson syndrome
  • Toxic epidermal necrolysis
  • Thrombocytopenia
  • Agranulocytosis
  • Aplastic anemia
  • Anemia, hemolytic
  • Neutropenia
  • Angioedema
  • Hyperkalemia
  • Anxiety
  • Athenia
  • Agitation
  • Oculogyric crisis
  • Urinary retension
  • Rhythm and heart rate disorders
  • Increased QT interval
  • Atrial fibrillation
  • Arrhythmia
  • Palpitation
  • Ventricular tachycardia
  • Bradycardia
  • Abnormal LFT
  • Serious ventricular arrhythmia
  • Torsades depointes
  • Anaphylaxis
  • Angioedema
How to Use

How to Use

Do not exceed the dose prescribed by your doctor.
Swallow the tablet whole immediately after opening it from the strip. Do not break/cut/chew it.
Avoid missing/forgetting a dose. If you do, take it as soon as you remember; but if it is almost time for your next dose, skip it and take it according to your normal schedule. Don’t consume two doses at the same time which may be dangerous to your health.
Take the medication at the prescribed time and dosage.

Overdosage

Avoid taking more than the prescribed dosage. In case of an accidental overdose, promptly seek medical advice. Depending on the dosage, symptoms may vary but you may experience one or more of the following signs or symptoms:

  • Gastrointestinal bleeding
  • Lethargy
  • Hypoprothrombinemia
  • Apnoea
  • Acidosis
  • Excitation
  • Fainting
  • Convulsions
  • Acute renal and liver damage
Warnings and Precautions

Warnings and Precautions

Take the Naprosyn D Tablet 250mg only on the advice of a medical practitioner. Dosage adjustment or complete avoidance of the medication may be required in the following conditions:

Kidney:

Caution advised among people with renal problems. If you have any, consult your doctor before the consumption of Naprosyn D Tablet 250mg.

Liver:

Caution advised among people with hepatic problems. If you have any, consult your doctor before the consumption of Naprosyn D Tablet 250mg.

Pregnancy:

Domperidone: Safety during pregnancy is unknown. Therefore, inform your doctor if you are pregnant or planning to become pregnant during the treatment.
Naproxen: Caution advised during 1st trimester, completely avoid using during the last months of pregnancy. However, inform your doctor if you are pregnant during the treatment and take the medicine only if it is suggested by your doctor.

Lactation:

Domperidone: Safety during lactation is unknown. Therefore, inform your doctor if you are a nursing mother during the treatment.
Naproxen: It may be used for short-term use. Based on human data, there are chances of GI bleeding and vomiting. Therefore, inform your doctor if you are a nursing mother during the treatment.

Drug Interactions:

Domperidone: This drug may antagonize the hypoprolactinaemic effect of bromocriptine. Also, antagonize the prokinetic effect with opioid analgesics and antimuscarinics etc.
Naproxen:The drug may increase the risk of bleeding with other NSAIDs or salicylates such as aspirin, and anticoagulants (e.g. warfarin), corticosteroids, etc. May decrease the efficacy of antihypertensive agents. Increased risk of nephrotoxicity of ciclosporin or tacrolimus. May increase the risk of hematological toxicity with zidovudine. Reduced natriuretic effects of diuretics. Therefore, inform your doctor about your current list of medication(s) during the treatment (if any).

Precautions
  • Keep the medicine out of sight and reach of children.
  • Store at room temperature away from heat and moisture.
  • Do not use the Naprosyn D Tablet 250mg beyond its expiry.
FDA Pregnancy Category

FDA Pregnancy Category

Category N: No information available.


Drug Composition information
What is Domperidone for:

This medication is an antidopaminergic agent, used in treating nausea, vomiting, gastrointestinal problems and Parkinson?s disease.

How does Domperidone work:

Domperidone helps the stomach get rid of food and lowers signs of an upset stomach, throwing up, heartburn, and fullness.

How should Domperidone be used:

Adult: Oral- Nausea and vomiting- 10-20 mg 4-8 hourly. Max: 80 mgday. Non ulcer dyspepsia- 10-20 mg 3 timesday and at night. Migraine- 20 mg 4 hourly. Max: 4 doses24 hour. Rectal- Nausea and vomiting- 60 mg twice daily. It is available in various forms like tablet, drop, suspension, capsule to take by mouth, on an empty stomach.

Common side effects of Domperidone :

Headache. Dry mouth. Good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help. See a dentist often

What do I do if I miss a dose

Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. Do not change the dose or stop this drug. Talk with the doctor.

What precautions should I take when taking Domperidone :

Alert your doctor if you have stomach problems (such as stomach bleeding or intestinal blockage) or prolactinoma (a tumour that releases a hormone called prolactin). - Alert your doctor if you have heart, liver or kidney disease, or if you have breast cancer. - Alert your doctor if you are pregnant or breastfeeding. Do not breastfeed while being treated with Domperidone.

When do I need to seek medical help

If you think there was an overdose, call your local poison control center or ER right away. Signs of a very bad reaction to the drug. These include wheezing; chest tightness; fever; itching; bad cough; blue or gray skin color; seizures; or swelling of face, lips, tongue, or throat. A fast heartbeat. Very bad dizziness or passing out. Seizures. Any rash. Side effect or health problem is not better or you are feeling worse.

Can I take Domperidone with other medicines:

Alert your doctor quickly if you are taking any of the following medications: - bromocriptine - heart medicines, especially those used to control irregular heartbeat. - antidepressants known as MAOI, such as phenelzine, isocarboxazid. - other mood medicines such as mesoridazine, thioridazine. - painkillers such as codeine, morphine. - Always inform your doctor and pharmacist if you are taking any other medicines, including herbal tonics, supplements and medicines that you buy without a prescription.

Are there any food restrictions

Avoid Alcohol

How do I store Domperidone :

Oral: Store it at controlled room temperature (15-30C).

Pregnancy Category

Category C : Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Therapeutic Classification

Antiemetics, GIT Regulators & Anti-Inflammatories

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