Diclofenac sodium/menthol/methyl salicylate/oleum lini

A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

Menthol is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. It is a waxy, crystalline substance, clear or white in color, which is solid at room temperature and melts slightly above. The main form of menthol occurring in nature is (-)-menthol, which is assigned the (1R,2S,5R) configuration. Menthol has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.

Each 100 g of cream contains methyl salicylate 11 g, eugenol 1.4 g, Methyl salicylate 5.6 g, cajuput oil 0.8 g and washable base.

Carefully consider the potential benefits and risks of Diclofenac sodium sodium delayed-release tablets and other treatment options before deciding to use Diclofenac sodium sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Diclofenac sodium sodium delayed-release tablets are indicated:

Oral

Nasal congestion; Throat irritation

Adult: As a loz (usually in combination with eucalyptus oil or cetylpyridinium chloride): 1 loz every 3 hr, to be sucked slowly.

Child: >6 yr: As a lozenge (usually in combination with eucalyptus oil or cetylpyridinium chloride): 1 lozenge every 3 hr, to be sucked slowly.

Topical/Cutaneous

Muscular aches and pains

Adult: As an ointment/cream (usually in combination with camphor, clove oil or methyl salicylate): Apply and rub gently onto the affected skin areas 2-3 times daily.

Methyl salicylate cream is for the temporary relief of pain associated with strains of joints and muscles, arthritis, rheumatism, lumbago, and fibrositis. Methyl salicylate cream can also be used for pre-sport warm-up and after sport as required.

Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain. However, Diclofenac sodium does not cure osteoarthritis and will help you only as long as you continue to use it.

Diclofenac sodium topical 3% gel is also used to treat actinic keratosis, a skin problem that may become cancerous if not treated. The exact way that topical Diclofenac sodium helps this condition is unknown.

Diclofenac sodium topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.

Diclofenac sodium topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).

Diclofenac sodium is available only with your doctor's prescription.

Relieving minor pain caused by conditions such as arthritis, backache, bruising, bursitis, cramping, muscle strains or sprains, and tendonitis. It may also be used for other conditions as determined by your doctor.

Menthol is a topical analgesic. It works by temporarily relieving minor pain.

Carefully consider the potential benefits and risks of Diclofenac sodium sodium extended-release tablets, and other treatment options before deciding to use Diclofenac sodium sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Diclofenac sodium sodium extended-release tablets the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of osteoarthritis, the recommended dosage is 100 mg daily.

For the relief of rheumatoid arthritis, the recommended dosage is 100 mg daily. In the rare patient where Diclofenac sodium sodium extended-release tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg twice a day if the benefits outweigh the clinical risks of increased side effects.

Different formulations of Diclofenac sodium (Diclofenac sodium sodium enteric-coated tablets; Diclofenac sodium sodium extended-release tablets; Diclofenac sodium potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

Oral

Nasal congestion; Throat irritation

Adult: As a loz (usually in combination with eucalyptus oil or cetylpyridinium chloride): 1 loz every 3 hr, to be sucked slowly.

Child: >6 yr: As a lozenge (usually in combination with eucalyptus oil or cetylpyridinium chloride): 1 lozenge every 3 hr, to be sucked slowly.

Topical/Cutaneous

Muscular aches and pains

Adult: As an ointment/cream (usually in combination with camphor, clove oil or methyl salicylate): Apply and rub gently onto the affected skin areas 2-3 times daily.

Apply generously on the affected area 2-3 times daily or whenever necessary.

See also:
What is the most important information I should know about Diclofenac sodium?

Diclofenac sodium in all formulations, Diclofenac sodium, Voltaren, and Voltaren-XR, is contraindicated in patients with known hypersensitivity to Diclofenac sodium and Diclofenac sodium-containing products. Diclofenac sodium should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to Diclofenac sodium have been reported in such patients.

See also:
What is the most important information I should know about Menthol?

Not to be used in

No known conditions.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

All NSAIDs are contra-indicated in patients with active peptic ulceration; in addition, the non-selective NSAIDs should be used with caution, if at all, in patients with a history of such disorders. To reduce the risk of gastrointestinal effects, NSAIDs may be taken with or after food or milk

Use Diclofenac sodium as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Diclofenac sodium comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Diclofenac sodium refilled.
• Do not apply Diclofenac sodium to infected skin; open wounds; or red, swollen, or peeling skin.
• Wash your hands immediately before and after using Diclofenac sodium.
• Wash the affected area and dry completely before using Diclofenac sodium.
• To apply Diclofenac sodium, dispense 10 drops at a time onto the knee or into your hand. Spread Diclofenac sodium evenly around the front, back, and sides of the knee. Repeat until you have used the whole dose.
• Be sure that you cover your entire knee with your dose of Diclofenac sodium. Do not use more than the recommended amount.
• Do not apply sunscreens, cosmetics, insect repellants, other topical medicines, or any other substance to the treated area until it is completely dry.
• Do not put on clothes over the treated area until it is completely dry.
• Do not wrap, bandage, or apply heat to the treated area.
• Let the treated skin dry before touching it or letting it touch anyone else's skin.
• Do not shower, bathe, or wash the treated area for at least 30 minutes after you use Diclofenac sodium.
• If you miss a dose of Diclofenac sodium, 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 Diclofenac sodium.

Use Menthol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before and right after using Menthol.
• Spray Menthol directly onto the affected area. Do not rub or massage the medicine into the skin.
• Do not wrap, bandage, or use a heating pad on the treated area.
• Do not apply Menthol more than 4 times daily.
• If you miss a dose of Menthol, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Menthol.

Diclofenac sodium is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat gout attacks.

How to use Diclofenac sodium

Read the Medication Guide provided by your pharmacist before you start using Diclofenac sodium and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a full glass of water (8 ounces /240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug. To prevent stomach upset, take this medication with food, milk, or an antacid.

There are different brands and forms of this medication available. Because different brands deliver different amounts of medication, do not switch brands of Diclofenac sodium without your doctor's permission and directions.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To minimize side effect risks (such as stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often than prescribed. For chronic conditions such as arthritis, continue taking it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.

For certain conditions (such as arthritis), it may take up to 2 weeks of regular use before the full benefits of this drug take effect.

If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Tell your doctor if your condition worsens.

Pharmaceutical Aid

Methyl salicylate is used as an anti-pain topical medication, as cream, gel, ointment, lotion or spray. It is used to temporarily relieve muscle or joint pain caused by strains, pains, arthritis, bruising or backaches.

See also:
What other drugs will affect Diclofenac sodium?

Aspirin: Concomitant administration of Diclofenac sodium and aspirin is not recommended because Diclofenac sodium is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations, peak plasma levels, and AUC values.

Anticoagulants: While studies have not shown Diclofenac sodium to interact with anticoagulants of the warfarin type, caution should be exercised, nonetheless, since interactions have been seen with other NSAIDs. Because prostaglandins play an important role in hemostasis, and NSAIDs affect platelet function as well, concurrent therapy with all NSAIDs, including Diclofenac sodium, and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.

Digoxin, Methotrexate, Cyclosporine: Diclofenac sodium, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Diclofenac sodium may increase serum concentrations of digoxin and methotrexate and increase cyclosporineís nephrotoxicity. Patients who begin taking Diclofenac sodium or who increase their Diclofenac sodium dose or any other NSAID while taking digoxin, methotrexate, or cyclosporine may develop toxicity characteristics for these drugs. They should be observed closely, particularly if renal function is impaired. In the case of digoxin, serum levels should be monitored.

Lithium: Diclofenac sodium decreases lithium renal clearance and increases lithium plasma levels. In patients taking Diclofenac sodium and lithium concomitantly, lithium toxicity may develop.

Oral Hypoglycemics:

Diuretics: Diclofenac sodium and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.

Other Drugs: In small groups of patients (7-10/interaction study), the concomitant administration of azathioprine, gold, chloroquine, D-penicillamine, prednisolone, doxycycline, or digitoxin did not significantly affect the peak levels and AUC values of Diclofenac sodium. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Diclofenac sodium therapy.

Protein Binding

In vitro, Diclofenac sodium interferes minimally or not at all with the protein binding of salicylic acid (20% decrease in binding), tolbutamide, prednisolone (10% decrease in binding), or warfarin. Benzylpenicillin, ampicillin, oxacillin, chlortetracycline, doxycycline, cephalothin, erythromycin, and sulfamethoxazole have no influence in vitro on the protein binding of Diclofenac sodium in human serum.

Drug/Laboratory Test Interactions

Effect on Blood Coagulation: Diclofenac sodium increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII. Statistically significant changes in prothrombin and partial thromboplastin times have been reported in normal volunteers. The mean changes were observed to be less than 1 second in both instances, however, and are unlikely to be clinically important. Diclofenac sodium is a prostaglandin synthetase inhibitor, however, and all drugs that inhibit prostaglandin synthesis interfere with platelet function to some degree; therefore, patients who may be adversely affected by such an action should be carefully observed.

Tell your doctor of any over-the-counter or prescription medication you may take including: blood thinners.

Do not start or stop any medicine without doctor or pharmacist approval.

Absorption of methyl salicylate through the skin can occur after excessive topical application, and interactions would be expected to be as for other salicylates

See also:
What are the possible side effects of Diclofenac sodium?

Ocular

Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Diclofenac sodium sodium ophthalmic solution, 0.1%. In cataract surgery studies, keratitis was reported in up to 28% of patients using Diclofenac sodium sodium ophthalmic solution, 0.1%, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery. Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery. The following adverse reactions were reported in approximately 10% or less of the patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.

Systemic

The following adverse reactions were reported in 3% or less of the patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection and vomiting.

Clinical Practice

The following reactions have been identified during postmarketing use of topical Diclofenac sodium sodium ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical Diclofenac sodium sodium ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration and epithelilal breakdown.

TO REPORT SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See also:
What are the possible side effects of Menthol?

May cause hypersensitivity reactions such as cutaneous dermatitis. Ingestion of large amount of menthol may cause GI effects such as severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness and coma.

See also:
What are the possible side effects of Methyl salicylate?

As aspirin, The most common adverse effects of therapeutic doses of aspirin are gastrointestinal disturbances such as nausea, dyspepsia, and vomiting. Gastrointestinal symptoms may be minimised by giving aspirin with food. Irritation of the gastric mucosa with erosion, ulceration, haematemesis, and melaena may occur. Histamine H2-antagonists, proton pump inhibitors, and prostaglandin analogues such as misoprostol may be used in the management of aspirin-induced mucosal damage. Slight blood loss, which is often asymptomatic, may occur in about 70% of patients; it is not usually of clinical significance but may, in a few patients, cause iron-deficiency anaemia during long-term therapy. Such occult blood loss is not affected by giving aspirin with food but may be reduced by use of enteric-coated or other modified-release tablets, H2-antagonists, or high doses of antacids. Major upper gastrointestinal bleeding occurs rarely.

Some persons, especially those with asthma, chronic urticaria, or chronic rhinitis, exhibit notable hypersensitivity to aspirin, which may provoke reactions including urticaria and other skin eruptions, angioedema, rhinitis, and severe, even fatal, paroxysmal bronchospasm and dyspnoea. Persons sensitive to aspirin often exhibit cross-sensitivity to other NSAIDs.

Aspirin increases bleeding time, decreases platelet adhesiveness, and, in large doses, can cause hypoprothrombinaemia. It may cause other blood disorders, including thrombocytopenia.

Aspirin and other salicylates may cause hepatotoxicity, particularly in patients with juvenile idiopathic arthritis or other connective tissue disorders. In children the use of aspirin has been implicated in some cases of Reye’s syndrome, leading to severe restrictions on the indications for aspirin therapy in children. For further details see under Reye’s Syndrome,.

Aspirin given rectally may cause local irritation; anorectal stenosis has been reported.