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Milnacipran | Savella | Joncia | Ixel is used to treat pain caused by a condition called fibromyalgia that affects the muscles, tendons, ligaments, and supporting tissues.

This medication is a serotonin-norepinephrine reuptake inhibitor (SNRI) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

Therapeutic Class

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Pharmacology

Milnacipran/ Savella is a potent inhibitor of neuronal norepinephrine and serotonin reuptake. It inhibits norepinephrine uptake with approx. 3-fold higher potency in vitro than serotonin with directly affecting the uptake of dopamine or other neurotransmitters.

Dosage

The recommended dose of Milnacipran is 100 mg/day (50 mg twice daily). Based on efficacy and tolerability dosing may be titrated according to the following schedule:

Day 1: 12.5 mg once
Days 2-3: 25 mg/day (12.5 mg twice daily)
Days 4-7: 50 mg/day (25 mg twice daily)
After Day 7: 100 mg/day (50 mg twice daily)

Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily). Doses above 200 mg/day have not been studied.

Administration

Should be taken with food. Preferably taken during meals.

Interaction

Increased risk of bleeding with aspirin, NSAIDs, warfarin and other drugs that affect coagulation. Increased CNS effects with centrally acting drugs (e.g. clomipramine). Increased risk of serotonin syndrome and NMS-like reactions with serotonergic drugs (e.g. tramadol), SSRIs, other selective

serotonin-norepinephrine reuptake inhibitors, 5-HT1 receptor agonists (e.g. sumatriptan), antipsychotic agents and other dopamine antagonists. May inhibit antihypertensive effect of clonidine. May potentiate adverse haemodynamic effects with digoxin.

Paroxysmal HTN and cardiac arrhythmia may occur when taken concurrently with epinephrine or norepinephrine.

Contraindications

Uncontrolled narrow-angle glaucoma. Concomitant use with MAOI or within 2 wk after withdrawal of MAOI.

Side Effects

Nausea, vomiting, dry mouth, constipation, loss of appetite, dizziness, increased sweating, headache, or hot flashes (flushing) may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat, changes in sexual ability, decreased interest in sex, painful/difficult urination, seizures, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, black/bloody stools, vomit that looks like coffee grounds, easy bruising/bleeding.

Savella medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section).

Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Pregnancy & Lactation

Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Milnacipran therapy. Patients should be encouraged to enroll in the

Milnacipran/ Savella Pregnancy Registry if they become pregnant, preferably before any prenatal testing is done. This registry is collecting information about the safety of milnacipran during pregnancy.

Nursing: Advise patients to notify their physician if they are breast feeding

Precautions & Warnings

Patient with major depressive disorder or other psychiatric disorders, history of dysuria, controlled narrow-angle glaucoma, pre-existing HTN, tachyarrhythmias or other CV disease, history of seizure disorder or condition predisposing to seizures (e.g. brain damage, alcoholism).

Avoid abrupt withdrawal. Severe hepatic and moderate to severe renal impairment including ESRD. Pregnancy and lactation.

Use in Special Populations

Renal Impairment: Severe (CrCl 5-29 mL/min): 25 mg bid, may increase to 50 mg bid according to response.

End stage renal disease (ESRD): Not recommended.

Pediatric use: Safety and effectiveness of Milnacipran in a fibromyalgia pediatric population below the age of 18 have not been established. The use of Milnacipran/ Savella is not recommended in pediatric patients.

Overdose Effects

Symptoms: Increased BP, cardio-resp arrest, changes in the level of consciousness (ranging from somnolence to coma), confusional state, dizziness, and increased hepatic enzymes.

Management: Symptomatic treatment with gastric lavage and activated charcoal. Maintain adequate airway, oxygenation and ventilation and monitor cardiac rhythm and vital signs. May give cyproheptadine with adequate temp control to treat serotonin syndrome.

Storage Conditions

Store at 25° C.