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Antidepressant, NSAIDS

Sertraline

INFORMATION FOR USE OF A MEDICAL

PRACTITIONER, HOSPITAL OR LABORATORY

SERTRALINE TABLETS

Available Composition
VLOFT

Each film coated tablet contains: Sertraline Hydrochloride eq. to Sertraline 50 mg

IMPORTANT WARNING:A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants (mood elevators) such as sertraline during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant.

PHARMACOLOGICAL CLASSIFICATION

Antidepressant
The mechanism of action of sertraline is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT). Studies at clinically relevant doses in man have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors; antagonism of such receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. The chronic administration of sertraline was found in animals to down regulate brain norepinephrine receptors, as has been observed with other drugs effective in the treatment of major depressive disorder. Sertraline does not inhibit monoamine oxidase.

PHARMACOKINETICS

Sertraline is slowly absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 4.5 to 8.5 hours after ingestion. It undergoes extensive first-pass metabolism in the liver. The main pathway is demethylation to N-desmethylsertraline which is inactive; further metabolism and glucuronide conjugation occurs. Sertraline is widely distributed throughout body tissues and highly bound to (98%) to plasma proteins. The plasma elimination half-life of sertraline is reported to be 24 to 26 hours. Sertraline is excreted in approximately equal amounts in the urine and faeces, mainly as metabolites. Sertraline is distributed into breast milk.

INDICATIONS

VLOFT is indicated for the treatment of:

· major depression,

· obsessive-compulsive disorder (OCD),

· posttraumatic stress disorder (PTSD),

· premenstrual dysphoric disorder (PMDD),

· panic disorder and

Social phobia (social anxiety disorder).

PATIENT INFORMATION:

BEFORE YOU TAKE VLOFT

Make sure you have told your doctor if you:

Are pregnant or think you may be pregnant, or are planning to become pregnant.
Are breast feeding.
Are allergic to sertraline or any other medications.
Have recently had a heart attack and if you have or have ever had seizures or liver or heart disease.

HOW TO TAKE VLOFT

You must take your medicine as the doctor tells you. It is important to take VLOFT Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness.

Dosage for Adults

Major Depressive Disorder - Sertraline treatment should be administered at a dose of 50 mg once daily.
Maintenance/Continuation/Extended Treatment
Major Depressive Disorder – It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of sertraline has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50-200 mg/day (mean dose of 70 mg/day)

IF YOU MISS A DOSE

Take the missed dose as soon as you remember it. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your doses as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the dose that you missed.

WHAT TO DO IF AN OVERDOSE IS TAKEN

In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. Treatment should consist of those general measures employed in the management of overdosage with any antidepressant. Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Due to large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for sertraline are known.

Symptoms of overdose may include:

· hair loss

· changes in sex drive or ability

· drowsiness

· excessive tiredness

· difficulty falling asleep or staying asleep

· diarrhea

· vomiting

· rapid, pounding or irregular heartbeat

· nausea

· dizziness

· excitement

· uncontrollable shaking of a part of the body

· seizures

· hallucinating (hearing voices or seeing things that do not exist)

· unconsciousness

· fainting

TAKING OTHER MEDICINE

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of VLOFT if you are taking any drug:

SIDE EFFECTS

Common side effects of VLOFT include:

Sertraline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

nausea
diarrhea
constipation
vomiting
dry mouth
gas or bloating
loss of appetite
weight changes
drowsiness
dizziness
excessive tiredness
headache
pain, burning, or tingling in the hands or feet
nervousness
uncontrollable shaking of a part of the body
sore throat
changes in sex drive or ability
excessive sweating

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

blurred vision
seizures
abnormal bleeding or bruising
hallucinating (seeing things or hearing voices that do not exist)

STORING

· Keep all medicines out of the reach of children.

· Store at room temperature(20 to 25°C)

Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice.