EFEXOR XR 37.5mg Pfizer Treatment Treatment of major depression disorders (1 blister x 7 tablets)

Dosage form Box of 1 blister x 7 tablets
Specifications Vendafaxine

Ingredient

Composition information	Content
Vendafaxine	37.5mg

Uses

indications

Efexor® XR is indicated in the following cases:

Treatment of major depression disorders. Calculated as O-Desmethidlvenlafaxin (ODV) are strong inhibitors in recovery of serotonin and norepinephrin and also inhibit dopamine recovery. The anti -depression effect of Venlafaxin is thought to be due to the ability to act on neurotransmitter activity in the central nervous system. Venlafaxin and ODV have no affinity with the Muscarinic receptor, histaminergic or aradrenergic in vitro. Effects in these receptors may be related to other effects found in other antidepressants such as cholin -resistant effects, sedative effects and effects on the cardiovascular system. In preclinical studies on rodents, Venlafaxin has shown antidepressant effects and anxiety effects, and increases cognitive ability.

Pharmacokinetics

absorption

at least 92% Venlafaxin is absorbed after taking the single -dose of venlafaxin on average. Absolute bioavailability of drugs from 40% to 45% due to metabolism before penetration into the general circulation. In the study of single dose with the dose of Venlafaxin, the average release of 25 to 150 mg, the average peak (CMAX) concentration in plasma is from 37 to 163 mg/ml, and is achieved within 2.1 to 2.4 hours (TMAX). After taking Venlafaxin capsule capsules for prolonged release, the peak concentration of the plasma of Venlafaxin and ODV reached the corresponding between 5.5 and 9 hours. After taking the Venlafaxin capsule capsules instantly, the peak concentration of the plasma of Venlafaxin and ODV reached the corresponding for about 2 hours and 3 hours. Venlafaxin capsules are prolonged and the Venlafaxin tablet releases the same level of absorption.

Distribution

The concentration in the stable state of both vendafaxin and ODV in plasma reaches within 3 days when treating the dose repeated with Venlafaxin instant release. Both substances have linear learning at the dose of 75 to 450 mg/day when taken every 8 hours. Venlafaxin and ODV are associated with plasma proteins, respectively, about 27% and 30%. Because the combination with plasma proteins does not depend on the concentration of the drug, respectively, up to 2,215 and 500 ng/ml, Venlafaxin and ODV are less likely to cause interaction related to the dispute associated with plasma proteins. Venlafaxin's distribution volume at a stable concentration is 4.4 ± 1.9 l/kg after intravenous injection.

Metabolism

venlafaxin is strongly metabolized in the liver. In Vivo and In Vitro studies show that Venlafaxin is converted into active substances mainly ODV through the P450 ISOENZYM CYP2D6 system. In Vivo and In Vitro studies show that Venlafaxin has been converted into a small part into n-DesmethylaLfaxin, metabolites with less activity, through CYP3A4. Although the relative activity of the CYP2D6 enzyme may vary among patients, it is not necessary to adjust the venlafaxin dose for these patients. The value of the area under the curve (AUC) of the drug and the variation of the plasma concentration of Venlafaxin and ODV is similar after using the daily dose level equivalent to the dose mode twice or three times a day Venlafaxin instantaneous.

Elimination

venlafaxin and its metabolites are excreted mainly through the kidneys. About 87%of Venlafaxin's doses were found in urine within 48 hours in the form of constant vendafaxin (5%), unmarried ODV (29%), conjugated ODV (26%) or secondary non -active metabolites (27%).

Effect of food

Food does not affect the absorption of Venlafaxin or the formation of ODV.

Hepatitis

Venlafaxin and ODV pharmacokinetics are changed significant in some patients with compensated cirrhosis (average liver failure) after taking single dose of Venlafaxin. In patients with liver failure, the average plasma clearance of Venlafaxin and ODV decreased by 30 to 33% and the average disposal time lasted by 2 times or more than the kidney diseases with normal liver function.

In a second study, Venlafaxin is taken orally and intravenously on normal patients (n = 21) and on patients with mild hepatitis Child-Pugh A (n = 8) and patients with average liver child-pugh b (n = 11), oral bioavails on patients with liver failure twice as much as the viability of medication in patients with normal liver function. In patients with liver failure, Venlafaxin's oral disposal time lasts about twice longer than 2 times and the oral clearance decreases more than half when compared to patients with normal liver function. In patients with liver failure, ODV's oral disposal time lasts about 40% while the oral clearance of ODV is similar to that of patients with normal liver function. The great variation between the individuals has been recorded.

Kidney failure

Venlafaxin and ODV waste time increases with the degree of renal failure. The selling time increased by about 1.5 times in patients with average renal failure and about 2.5 times and 3 times in patients with end -stage renal impairment.

Studies on age and gender

Popular pharmacokinetics analysis on 404 patients treated with Venlafaxin instantaneously in two studies using drugs twice and three times a day shows that the base concentration in plasma has been adjusted according to the dose that is not affected by age or gender.

Before taking EFEXOR XR 37.5mg Pfizer Treatment Treatment of major depression disorders (1 blister x 7 tablets)

How to use

prolonged release capsules should be used with food and should be used at the same time every day. Take whole capsules with water, do not split, chew or dissolve capsules, or can be used by opening the follicle carefully and sprinkle all the amount of medicine in the cyst into a spoon full of apple sauce. Then swallow this medicine/food mixture, (do not chew) and drink a cup of water to make sure you have all the microfotors.

Dosage

Main depression disorders

The starting dose of the long -lasting Venlafaxin capsule is recommended as 75 mg, once used a day. Patients do not respond to the starting dose of 75 mg/day may increase the dose to the maximum dose of 225 mg/day.

Despite the recommended dose of the Venlafaxin tablet in the instant release for depression patients at an average level of up to 225 mg/day, a study showed that patients with severe depression responded to an average dose of 350 mg/day (ranging from 150 to 375 mg/day).

All anxiety disorders

The starting dose of the long -lasting Venlafaxin capsule is recommended as 75 mg, once used a day. Patients who do not respond to the starting dose of 75 mg/day may increase the dose to the maximum dose of 225 mg/day. It should be noted to monitor and evaluate patients during treatment.

Social anxiety

The starting dose of the long -lasting Venlafaxin capsule is recommended as 75 mg, once used a day. There is no evidence that increasing the dose increases the effectiveness of the drug's treatment. It should be noted to monitor and evaluate patients during treatment.

panic disadvantages

The dosage of the long -lasting Venlafaxin capsule is recommended for 37.5 mg/day for 7 days. After that, the dose should be increased to 75 mg/day. Patients who do not respond to a dose of 75 mg/day may increase the dose to the maximum dose of 225 mg/day. Need to monitor and evaluate patients during treatment.

How to stop Venlafaxin

When stopping treatment with Venlafaxin, it is gradually reduced at any time possible. In clinical strict tests with prolonged release Venlafexin capsules, the dose reduction process is done by reducing 75 mg /day, the time between the dose reduction time is 1 week. The time needed to reduce the dose depends on the dose, treatment time and response of each patient.

Use drugs for patients with renal failure

For patients with renal insufficiency with glomerular filtration level (GFR) from 10 to 70 ml/min, it should be reduced from 25% to 50% of the total daily doses of venlafaxin.

For patients who are in via blood, 50% of the total daily dose of Venlafaxin.

Due to a major change in the clearance between patients, individual dosage needs for each patient.

Use drugs for liver function impairment

For patients with hepatic failure from mild to medium level, it is advisable to reduce 50% of the total dose of venlafaxin daily. In some patients, it is possible to reduce more than 50% of the doses of venlafaxin.

Due to a major change in the clearance between patients, individual dosage needs for each patient.

Use drugs for children and teenagers

There is no enough data for using Venlafaxin in patients under 18 years old.

Use drugs in elderly patients

No special dose adjustment is recommended based on the patient's age.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? The reports often encounter cases of overdose including tachycardia, changing levels of consciousness (from drowsiness to coma, dilated pupils, convulsions and vomiting. Other reports include changes on the electrocardiogram (e.g., extending the QT, branch block, prolonged QRS interval), ventricular tachycardia, slow heart rate, lower blood pressure, dizziness, and death.

recommended treatment measures:

Take measures to support and treat symptoms; Heart rate monitoring and important birth rate. Specific antidote for vendafaxin.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Efexor® XR, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Body: weakness, fatigue, chills Plasma cholesterol (especially when used for prolonged and can occur when high doses), weight loss. Night).

Uncommon, 1/1000

Systemic body: Evaluation, light -sensitive reactions Weigh.

Rare, ADR

Systemic: Anaphylaxis. The liver, the incomplete secretion syndrome (SIADH), increased prolactin secretion. Slowly.

Skin: epidermal necrosis.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

EFEXOR® XR is contraindicated in the following cases:

Hypersensitivity to Venlafaxin or any ingredients of the drug. This distance may be shortened in case of recovery Maoi. Venlafaxin should be stopped at least 7 days before treatment with Maoi drugs.

Precautions when using

Tu Death/Integration of suicide or deterioration of clinical illness:

All patients treated with Venlafaxin should be carefully monitored and closely observed signs of deteriorating clinical scenes and if the patient intends to commit suicide. Patients, families, and patients care for patients need to be reminded of always alert about the appearance of signs of anxiety, excitement, panic attacks, insomnia, uneasiness, hostile attitude, aggression, impulsive, restless sitting (Akathisia), mild manic, abnormal changes in behaviors, symptoms of deterioration, and special intentions, and special intentions, and intentions, and intentions, and intentions, and intentions, and intentions to be self -treated, and special intentions, and intentions when they start to treat, and have any suicidal intentions Dose mode. The risk of suicide must be considered, especially in depression patients, and the lowest dose should be accompanied by tight patients monitoring to reduce the risk of overdose.

Fracture:

Epidemiological research shows that the risk of fractures increases in patients taking serotonin recovery inhibitors including venlafaxin. The mechanism that causes this risk has not been completely clarified.

Use drugs for children and teenagers

The effect of drugs in patients under 18 years of age has not been clearly defined.

Should regularly monitor weight and measure blood pressure for children and teenagers to use Venlafaxin. Venlafaxin should be stopped for children and teenagers with continuous hypertension. If treatment for a long time should check serum cholesterol levels. The safety of the drug when used for children under 6 years old has not been evaluated.

Similar reactions to malignant neuron syndrome (NMS)

Similar to other drugs on other serotonergic systems, serotonin syndrome or reactions similar to neuroleptic malignant syndrome (NMS) that threaten life -threatening may appear during Venlafaxin treatment, especially when used simultaneously with other Serotonergic drugs (including SSRLS, SNRIS and SNALL, FENTANL, FENTANY, FENTANY, FENTANY, FENTANY, FENTANY, FENTANL, FENTANY Dextromethorphan, Tramadol, Tapentadol, Meperidin, Methadon, Pentazocin), or with drugs that reduce serotonin metabolism (including Maois, Methylene Blue), or with other anti -psychotic drugs, other dopamine antagonists. Serotonin syndrome symptoms may include mental changes (for example: agitation, hallucinations, and coma), automatic nervous system disorders (for example: tachycardia, unstable blood pressure and hyperthermia), neuromuscular abnormalities (for example, increased reflexes, loss of coordination) with or not accompanied by digestive symptoms (for example, nausea, vomiting).

Serotonin syndrome may be similar to malignant neuroleptic syndrome, including hyperthermia, muscle stiffness, automatic nervous system disorders that can be accompanied by a rapid change in survival signs and mental changes.

In case of simultaneous use of venlafaxin with other drugs that affect the neurotransmitter system related to serotonin and/or dopamine, patients need closely monitoring, especially when starting treatment and when increasing dose. It is not recommended to simultaneously use venlafaxin with pre -quality of serotonin (such as Tryptophan supplementation).

Glaucom closed angle:

Delivering pupils may appear when using Venlafaxin. Patients with glaucoma or patients at risk of acute closed angle should be closely monitored.

cardiovascular system:

venlafaxin has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Therefore, be cautious when using vendafaxin for these people.

Dosage hypertension depends on the number recorded in some patients using vendafaxin. Cases of hypertension needed immediately treated during monitoring after the drug has been circulating in the market, patients who need to treat Venlafaxin are recommended to check blood pressure, as well as need careful survey of the patient's hypertension before. Caution should be careful for patients with potential diseases that can worsen due to increased blood pressure.

There may be an increase in heart rate, especially when used in high doses. Caution should be used when taking drugs for patients with hidden pathologies that can worsen due to an increase in the heart rate. Cases of extending the QT, nailing (TDP), ventricular tachycardia and sudden death have been reported during the circulation of the drug. Most reports occur due to overdose medication or in patients with other risk factors that cause QT/Twist. Therefore, Venlafaxin should be used cautiously in patients with risk factors that cause extension of QT.

convulsions:

SEASONS may occur when treated with Venlafaxin. Similar to other antidepressants, should be cautious when taking venlafaxin for patients with a history of convulsions.

Heart/Mild Heart:

Mild mania/mild mania may appear on a small percentage of patients with mental disorders using antidepressants, including vendafaxin. Similar to other antidepressants, should be cautious when using Venlafaxin for patients with a history of themselves or families with bipolar disorders.

aggressive:

The aggressive attitude may appear on a small percentage of patients taking antidepressants, including Venlafaxin treatment, in this case, the dose should be reduced or stopped taking the drug. Similar to other antidepressants, should be cautious when using venlafaxin for patients with a history of aggressive and aggressive attitude before.

Lower blood sodium:

Cases of hypoglycry hypoglycatry and/or incomplete secretion syndrome (SIADH) may appear when using Venlafaxin, common in dehydrated patients or reduced volume of circulatory. Elderly patients, patients who use diuretics and patients with reduced distribution of the distribution due to other causes are at higher risk of blood sodium lowering.

Bleeding:

Serotonin recovery inhibitors can affect platelet collection.

There have been reports on abnormal bleeding when using vendafaxin, from skin bleeding, mucosa and black gastrointestinal bleeding. Hemorrhage can be life -threatening.

Similar to other serotonin re -inhibitors, caution should be used with Venlafaxin carefully for patients at risk of bleeding, including patients who are taking anticoagulants and platelet aggregation inhibitors.

Losing weight:

Safety and effectiveness when combining Venlafaxin with weight loss pills, including Phentermin, has not been firmly determined. Simultaneous use of venlafaxin hydrochloride and weight loss pills are not recommended. Venlafaxin Hydrochorid is not indicated to use alone or in combination with other drugs to lose weight.

Serum cholesterol:

Hypered cholesterol has clinical significance recorded over 5.3% of patients treated with Venlafaxin and 0% in groups of placebo patients for at least 3 months in clinical studies with placebo. Serum cholesterol should be measured during long -term treatment.

Stop taking medicine:

The effects of stopping drugs that have been well known often occur when taking antidepressants, so with any form of venlafaxin preparation, it is necessary to gradually reduce the dose when stopping the drug and monitor patients carefully.

Abuse and drug dependence:

Clinical studies do not show evidence of drug dependence, tolerance, or dose increasing over time.

The ability to drive and operate machinery

venlafaxin does not affect the mental mental, awareness or implementation of complex actions on healthy volunteers. However, any mental medicine can reduce the ability to judge, think and motor skills. Therefore, patients should be cautious when driving or operating machinery.

Pregnancy

Venlafaxin's safety when used for pregnant women has not been set. Venlafaxin should only be used for pregnant women when the benefits surpassing the risk of being able to encounter. If using vendafaxin until birth or date of birth, the effect of stopping medication on infants should be considered. Some babies exposed to Venlafaxin during the late three months of pregnancy may appear complications that require feeding through catheter, respiratory support or prolonged hospital stay. These complications may appear immediately after birth.

The period of breastfeeding

venlafaxin and ODV are excreted through breast milk, so it is necessary to decide not to breastfeed or stop using Venlafaxin.

Interactive drug

Monoamine enzyme inhibitors (MAII)

Serious unwanted effects have been recorded in patients who have stopped using Maoi and start using vendafaxin, or have just stopped treating with vendafaxin to start using Maoi. These reactions include tremor, muscle vibration, sweating, nausea, vomiting, flushing, dizziness and hyperthermia with signs similar to malignant neuroleptic syndrome, convulsions, and death.

Medicines on central nervous system

The risk of using Venlafaxin in combination with other central nervous effects has not been systematically evaluated. Therefore, it is necessary to be cautious when using venlafaxin in combination with other central nervous effects.

Serotonin syndrome

Similar to other serotonergic drugs, serotonin syndrome, potentially life -threatening, may appear when treated with Venlafaxin, especially when used with the same drugs that affect the Serotonergic neurotransmitter (including Triptan, SSRI, SSRI, other Snris, Lithium, Sibutramine, Fentanyl and substances, Tramadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Dexadol, Tramadol Tapentadol, Meperidin, Methadon, Pentazocin, or St. John's Wort (Hypericum Perforatum), or with drugs that reduce Serotonin metabolism (such as MAII, including Linezolid.

If clinically, it is necessary to simultaneously use Venlafaxin and a SSRI, SNRIS or a 5-Hydroxyryptamine (Triptan) receptor. Simultaneous use of venlafaxin with pre -substances of serotonin (such as tryptophan supplements) is not recommended.

The drugs that extend the distance QT:

The risk of extending the range of QT and/or ventricular arrhythmias (for example: Twisted) increases when using simultaneously Venlafaxin and the drugs also cause a extension of QT (for example, anti -psychotic and antibiotic drugs)

indinavir

Dynamic pharmacokinetic research when using Venlafaxin along with indinavir shows that the area under the curve (AUC) of Indinavir is reduced by 28% and CMAX decreased by 36%. Indinavir does not affect the pharmacokinetics of Venlafaxin and O-Desmethidilvenlafaxin (ODV). The clinical meaning of this interaction is not known.

ethanol

Venlafaxin has been shown not to increase mental decline and motor skills caused by ethanol. However, like all medications on the central nervous system, patients are advised not to drink alcohol while taking Venlafaxin.

Haloperidol

Pharmacokinetics research shows that: Haloperidol's oral clearance decreases by 42%, the area under the curve increases by 70%, CMAX increases by 88%, but does not change the sale time of Haloperidol, should consider this when the patient is treated simultaneously with Haloperidol and Venlafaxine.

cimetidine

In a stable state, cimetidine inhibits the first liver metabolism of Venlafaxine. However, cimetidine does not affect the pharmacokinetics of ODV. The pharmacological effect of Venlafaxin and ODV is expected to only increase slightly in most patients. In elderly patients or patients with liver dysfunction, this interaction may be more pronounced.

imipramin

venlafaxin does not affect the pharmacokinetics of imipramin and 2-oh-Imipramin. However, AUC, CMAX and CMIN of desipramine increased by about 35% when there was Venlafaxin. AUC of 2-OH-Desipramin increased by 2.5 to 4.5 times. Imipramin does not affect Venlafaxin and ODV's pharmacies. This should be considered when the patient is treated simultaneously with imipramine and venlafaxin.

ketoconazole

Dynamic pharmacokinetic research with Ketokonazole in patients with normal metabolic (Em) and poor metabolic patients (PM) via CYP2D6 shows that the concentration of both Venlafaxin and ODV in plasma is higher after taking Ketokonazol. Venlafaxin's CMAX increased by about 26% in normal metabolic patients and 48% in poor metabolic patients. ODV's CMAX increased by 14% in normal metabolic patients and 29% in poor metabolic patients. Venlafaxin's AUC increased by 21% in normal metabolic patients and 7% in poor metabolic patients. The value of AUC ODV increased by 23% and 33% respectively on normal metabolic patients and poor metabolic patients.

metoprolol

Research on pharmacokinetic salary on healthy volunteers using simultaneously Venlafaxin (50 mg every 8 hours in 5 days) and Metoprolol (100 mg/day for 5 days) showing plasma metoprolol levels increased by about 30% - 40% while the concentration of metabolites is active as α -hydroxymetoprolol in non -changing plasma. In this study, Venlafaxin reduces the hypotension effect of Metoprolol. The clinical significance of this result in hypertension patients is not well known. Metoprolol does not change the pharmacokinetics of Venlafaxin or ODV, conducting the active metabolites of this drug. Be careful when using simultaneously venlafaxin and metoprolol.

risperidon

Venlafaxin increases the AUC of Risperidon about 32% but does not change the meaning of the pharmacokinetic parameters of active components (Risperidon and 9-Hydroxyperidon). The clinical significance of this interaction is not well known.

diazepam

Diazepam does not affect the pharmacokinetics of Venlafaxin or ODV. Venlafaxin does not affect Diazepam's pharmacokinetics and pharmacokinetics and its active metabolites are desmethyldiazepam.

lithium

pharmacokinetics in the stable state of Venlafaxin and ODV are not affected when used in the same lithium. Venlafaxin does not affect lithium pharmacokinetics.

Strong drugs with plasma proteins

venlafaxin binds to plasma proteins at a low rate (27%); Therefore, Venlafaxin when used for patients who are taking another drug with a ratio combined with high plasma protein may not increase the concentration of free drugs.

Metabolic drugs through isenzyme cytochrom P450

Studies show that Venlafaxin inhibits relatively weak CYP2D6. Venlafaxin does not inhibit CYP3A4, CYP1A2 and CYP2C9 in vitro. This result is re -confirmed on in vivo studies with the following drugs; Alprazolam (CYP3A4), caffeine (CYPIA2), Carbamazepin (CYP3A4), Diazepam, (CYP3A4 and CYP2C19), and Tolbutamid (CYP2C9).

The effects of other drugs on Venlafaxin

venlafaxin is metabolized through CYP2D6 and CYP3A4. Venlafaxin is converted weakly into active metabolites, ODV through the cytochrom P450 CYP2D6 enzyme system. Metabolic through CYP3A4 is Venlafaxin's sub -transformation path.

CYP2D6 inhibitors

Simultaneous use of Venlafaxin and CYP2D6 inhibitors can reduce the converting vendaStaxin into ODV, increasing the concentration of venlafaxine in plasma and reducing ODV's concentration. Because Venlafaxin and ODV are the same lacquered substances, so it is not necessary to adjust the dose when using Venlafaxin with CYP2D6 inhibitors.

CYP3A4 inhibitors

Simultaneous use of venlafaxin and CYP3A4 inhibitors can increase the concentration of vendafaxin and ODV. Therefore, it is necessary to be cautious when combining venlafaxin with CYP3A4 inhibitors.

CYP2D6 and CYP3A4 inhibitors

There has been no research on simultaneous use of venlafaxin with CYP2D6 and CYP3A4 inhibitors, the main enzymes involved in the metabolism of venlafaxin. However, this combination may increase the venlafaxine concentration in plasma. Therefore, it should be noted when combining venlafaxin with any drug inhibitors and this 2 enzyme system.

Electrical therapy

There is no clinical data on the effectiveness when combining electric therapy with Venlafaxin.

Drug interaction - Testing

Urine immune screening tests for fake positive results with PCP and Amphetamine have been reported in patients to stop vendafaxin. This result may be due to poorly specific screening tests. The false positive result may also be seen after a few days of stopping using Venlafaxin. The tests to confirm, such as gas chromatography or mass method will help distinguish vendafaxine from PCP and Amphetamine.

Storage

Store at temperatures below 30 ° C.

Projecting Venlafaxin capsules for 37.5 mg to avoid light and leave the drug in the packaging to avoid light.

Store venlafaxin in closed packaging.

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