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Voltral Tablets Uses Dosage Details

Voltral Tablets contains Diclofenic Sodium in it. Diclofenic Sodium is a NSAID a simple phenylacetic acid derivative. On the other hand It resembles both flurbiprofen and meclofenamate. It reduces fever and inflammation and relieves pain.

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Voltral Tablets Uses & Indications

Voltral(Diclofenac Sodium) tablets use for the treatment of:

• Inflammatory and degenerative forms of rheumatism: rehumatoid arthritis, juvenilr reheumatoid arthritis, ankylosing spondylitis, osteoarthritis. Further spondylarthritis, painful syndromes of the vertebral column, non-articular rhumatiosm.
• Acute attacks of gout.
• Post-traumatic and post-operative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery.
• Painful and/or inflammatory conditions in gynecology e.g. primary dysmenorrhea or adnexitis.
• Migraine attacks.
• As an adjuvant in severe painful inflammaotry infections of the ear, nose or throat. e.g. pharyngotonsillitis, otitis. On the other hand In keeping with general therapeutic principles, the underlying disease should treated with basic therapy, as appropriate. Fever alone not an indication.

Voltral (Diclofenac Sodium) Tablets Dosage Administration

Most importantly as a general recommendation Voltral dose should individually adjusted according to the condition of a patient and only professional physician or pharmacist must do it. On the other hand Side effects may minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Voltral (Diclofenac Sodium) Tablets Dosage For Adults

However initial daily Voltral Dose is normally 100 to 150 mg. In milder cases, as well as for long-term therapy, 75 to 100 mg daily is usually sufficient. On the other hand the total daily dose should generally divided into 2 to 3 separate doses. Further To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can supplemented by the administration of a suppository at bedtime (up to a total maximum daily dose of 150 mg) advice.

Meanwhile In primary dysmenorrhea, the daily dose should individually adjusted and generally 50 to 150 mg. A dose of 50 to 100 mg given initially. However, if needs to increased over the course of several menstrual cycles up to a maximum of 200 mg/day. On the other hand Treatment should started on appearance of the first symptoms and depending on the symptomatology, continued for a few days.

Meanwhile Treatment of migraine attacks with the medicine suppositories should started with a dose of 100 mg at the first signs of an impending attack. In addition suppositories up to 100 mg may taken same day if required. Further Should the patients require further therapy on the following days, the maximum daily dose should limited to 150 mg in divided doses.

Special Populations

Pediatric Patients (below 18 years of age)

Children who aged from 1 years or over and adolescents must use 0.5 to 2 mg/kg body weight daily into 2 to 3 separate doses. Meanwhile it depend on the severity of the disorder. However For treatment of juvenile rheumatoid arthritis, the dose can raised up to a maximum of mg/kg daily given in divided doses. Most importantly The maximum daily dose of 150 mg should not exceeded.

On the other hand Voltral 12.5 mg or 25 mg suppositories recommended for use in children and adolescents below 14 years of age. Because of their dosage strength Voltral 50 mg suppositories recommended for use in children and adolescents blow 14 years of age. However Voltral 100 mg suppositories must not use in children and adolescents as it is not suitable for children and adolescents.

Geriatric Patients (aged 65 years or above )

No adjustment of the starting dose generally required for elderly patients. However, caution indicated on basic medical grounds especially for frail elderly patients or those with a low body wight.

Established Cardiovascular Disease Or Significant Cardiovascular Risk Factors

Treatment with Voltral generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension. But If needed, patients with established cardiovascular disease, uncontrolled hypertension. Or significant risk factors for cardiovascular disease should treated with this medication only after careful consideration.

Renal Impairment

Voltral contraindicated in patients with renal failure (GFR<15 mL/min/1.73 m2). On the other hand no specific studies have carried out in patients with renal impairment. Therefore, no specific dose adjustment recommendations can made. But, caution advised when administering the medication to patients with renal impairment.

Hepatic Impairment

Votral contraindicated in patients with hepatic failure. However No specific studies have carried out in patients with hepatic impairment. So therefore, no specific dose adjustment recommendations can made. Meanwhile Caution is advised when administering it to patients with mild to moderate hepatic impairment.

Method Of Administration

The suppositories should inserted well into the rectum. On the other hand recommended to take the suppositories after passing stools.

Not to be taken by mouth, as for rectal use only.

Medicine Contraindications

• Known hypersensitivity to the active substance or to any of the other excipients.
• Active gastric or intestinal ulcer, bleeding or perforation.
• Last trimester of pregnancy.
• Hepatic failure.
• Renal failure.
• Like other non-steroidal anti-inflammatory products (NSAIDs). Furthermore, Voltral Medicine also contraindicated in patients whom the use of acetylsalicylic acid. Or other NSAIDs can precipitate asthma, angiodema, urticaria, or acute rhinitis (i.e. NSAID-induced cross-reactivity reactions).

Voltral Tablets Side Effects

Voltaren Tablets Side Effects from clinical trials and/or spontaneous or literature case are listed by medDRA system class. Within each system organ class, the side effects ranked by frequency, with the most frequent reactions first. Within each frequency groups the adverse reactions shown in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction based on the following convention (CIOMS 111):

• Very common (>/- 1/10)
• Common (>/- 1/100 to <1/10)
• Uncommon (>/- 1/1,000 to < 1/100)
• Rare (>/- 1/10,000 to < 1/1,000)
• Very rare (< 1/10,000).

The following Voltaren side effects include those reported with suppositories and/or other pharmaceutical forms of diclofenac. with either short-term or long-term use.

Blood And Lymphatic System Disorders

Very Rare : Thrombocytopenia, leukopenia, anemia(including hemolytic and aplastic), agranulocytosis.

Immune System disorders

Rare : Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).

Very Rare : Angioedema (including face edema).

Psychiatric Disorders

Very Rare : Disorientation, Depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous System Disorders

Common : Headache, dizziness.

Rare : Somnolence.

Very Rare : Paresthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, cerebrovascular accident.

Eye Disorders

Very Rare : Visual Impairment, blurred vision, diplopia.

Ear And Labyrinth Disorders

Common : Vertigo.

Very Rare : Tinnitus, impaired hearing.

Cardiac Disorders

Uncommon : Myocardial infarction, cardiac failure, palpitations, chest pain.

Vascular Disorders

Very Rare : hypertension, vasculitis.

Respiratory, Thoracic And Mediastinal Disorders

Rare : Asthma (including dyspnea).

Very Rare : Pneumonitis

Gastro Intestinal Disorders

Common : Nausea, vomiting, Diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite

Rare : Gastritis, gastrointestinal hemorrhage, hematemesis, hemorrhagic diarrhea, melena, gastrointestinal ulcer, proctitis.

Very Rare : Colitis, constipation, stomatitis, glossitis, esophageal disorder, intestinal diaphragm disease, pancreatitis, hemorrhoids.

Hepatobiliary Disorders

Common : Transaminases increased

Rare : Hepatitis, jaundice, liver disorder

Very Rare : Fulminant hepatitis, hepatic necrosis, hepatic failure

Skin And Subcutaneous Tissue Disorders

Common : Rash

Rare : Urticaria

Very Rare : Bullous dermatitis, eczema, erythema, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, alopecia, photosensitivity reaction, purpura, henoch schoenlein purpura, pruritus.

Renal And Urinary Disorders

Very Rare : Acute kidney injury, hematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis

General Disorders And Administration Site Condition

Common : Application site irritation

Rare : Edema

Description Of Selected Adverse Reactions

Arteriothrombotic Events

Meta-analysis and pharmacoepidemological data point towards a small increased risk of arteriothrombotic event associated with the use of Diclofenac, particularly at a high dose (150 mg daily ) during long-term treatment.

Visual Effects

Visual disturbances such as visual impairment, blurred vision or diplopia appear to be NSAID class effects and are usually reversible on discontinuation. A likely mechanism for the visual disturbances inhibition of prostaglandin synthesis. And other related compounds that alter the regulation of retinal blood flow resulting in potential changes in vision. However If such symptoms occur during Diclofenac Use, an ophthalmological examination may considered to exclude other causes.

Drug Interactions Information

The following Interactions observed when the treatment with this medicine is needed

CYP2C9 Inhitors:

Caution is recommended when co-prescribing diclofence with CYP2C9 inhibitors (such as voriconazole), which could result result in a sinificant increase in peak plasma concentrations and exposure to diclofenac.

Lithium:

If used concoitantly, diclofenac may raise plasma concentrations of lithium. Monitoring of the serum lithium levels is recommended.

Dioxin:

If used concoitantly, diclofenac may raise plasma concentrations of lithium.Monitoring of the serum digoxin level is recommended.

Diuretics And Anti Hypertensive Agents;

Like other NSAIDs, concomitant use of diclofence with diuretics or antihypertensive agents (e.g. beta-blockers, angiotension converting enzyme (ACE) inhibitors ) may cause a decrease in their antihypertensin effect. Therefore, the combination of these medicine must administered with caution and patients especially the elderly should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to thereafter, particularly for adequately hyprated. And monitoring of renal function after initiation of concomitant therapy must initiated. Or periodically thereafter, mainly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity.

Ciclosporin And Tacrolimus;

Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin and tacrolimus due to the effect on renal prostaglandin. Terefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrollimus.

Products known To Cause Hyperkalemia:

Concomitant treatment with with potassium-spar-increased serum potassium levels, which should therefor be monitored frequently.

Quinolone Antibacterials:

There have been isolated reported of convulsions which may have been due to conconitant use of quinolones and NSAIDs.

 

Voltral Use In Pregnancy And Breast Feeding

Women Of Child-Bearing Potential

There are no data to suggest any recommendations for women of child bearing potential.

Voltral Tab Use In Pregnancy

There are insufficient data on the use of Voltaren in pregnancy. However some epidemiological studies an increased risk of miscarriage after use of a prostaglandin sythesis inhibitor in early pregnancy. However the overall data inconclusive. Meanwhile the capsules should not used during the first two trimeters of pregnancy unless the expected benefits to the mother outweight the risks to the fetus. As with other NSAIDs use of Diclofenac during the third trimester for pregnancy contraindicated owing to the possibility of uterine inertia. Or in Fetal renal impairment with subsequent oligohydramnios and premature closure of the ductus arteriosus.

Use During Breast Feeding

Breast-feeding Like other NSAIDs , diclofenac passes into breast milk in small amounts. Therefore, it should not administration during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of the capsules may impair female fertility and not recommended in women attempting to conceive. In women have difficulties conceiving. Or who undergoing investigation of infertility, withdrawal of the medicine must be stopped.

Overdosage Symptoms & Treatment Guide

Symptoms

However no clinical data yet available for Voltral (Diclofenac) tab overdosage symptoms. Meanwhile overdosage can cause symptoms such Like.

• Vomiting
• Gastrointesinal Hemorrhage
• Diarrhea
• Diziness
• Tinnitus
• Convulsions

So, In the event of significant poisoning, acute renal failure and liver damage are possible. If you discover any of the effects you must immediately reach to the hospital or contact your doctor for further assistance.

Therapeutic Measures

Most importantly the management of acute poisoning with NSAIDs, including diclofenac, esentially consists of supportive measures and symptomatic treatment. However supportive measures and symptomatic treatment should given for complications Like

• Hypotension
• Renal failure
• Convulsions
• Gastronintestinal disorder
• Respiratory depression.

On the other hand Special measures such as forced diuresis, dialysis or hemoperfusion probably of no help in elimination NSAIDS. Which also include diclofenac, due to the high protein binding and extensive metabolism.

Voltral Tablets Storage Instructions

Most importantly always keep all the tablets, injections and syrups out of the reach of the children. On the other hand keep the tablets within 25 c to 30 c temperature. Further protect from direct sunlight, heat and moisture. Furthermore, do not use the medicine after the expiry date mention on the packing.

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Voltral (Diclofenac Sodium) Tablets Price (Rs. 577 PKR) & $ 5 USD In USA