Savi Sertraline 50 medicine treats depression, panic disturbance (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Sertraline
Ingredient
| Composition information | Content |
| Sertraline | 50mg |
Uses
indications
Savi Sertraline 50 drug is indicated in the following cases:
Sertralin, naphthylamin's derivative, is an antidepressant inhibiting Serotonin reabsorption (5-Hydroxytryptamin, 5-HT).
Little or no inhibiting noradrenalin or dopamine recovery effect and has no much anti-cholinergic, antihistamine or alpha or beta-adrenermic blockers at the treatment doses. Therefore, the common side effects due to Muscarin receptors (such as dry mouth, blurred vision, urinary retention, constipation, confusion), alpha-adrenergic receptors (such as decreased posture blood pressure) and H1 and H2 histamine receptors (such as drowsiness) are lower in sertralin users compared to anti-depressive drug users with three-round antidepressants and some other antidepressants. Sertralin does not inhibit monoaminoxidase.
Use the dose of treatment (50 - 200 mg/day) for healthy people, Sertralin inhibits the reabsorption of serotonin into platelets depending on the dose. Using a prolonged sertralin in animals has reduced the norepinephrin receptors in the brain as seen with other antidepressants and anti -obsession effectively effective in clinical.
Dynamic pharmacokinetics
Sertralin slowly absorbed through the gastrointestinal tract. Human bioavailability has not been fully evaluated because there is no intravenous form. In animals, the bioavailability of Sertralin is about 22 - 36% and the use of oral tablet is equivalent to oral solution.
If taking tablets along with food, area under the curve (AUC: Area Under Curve), the peak concentration increases by about 25% and the time of reaching the peak concentration decreases from 8 hours to 5.5 hours. If you take the solution with food, the time to achieve the peak plasma concentration increases from 5.9 to 7.0 hours.
Time to reach the peak concentration of about 4.5 - 8.5 hours after taking 50 - 200 mg once a day, 14 days. The peak concentration and bioavailability of the increased drug in the elderly. The drug reaches a stable state after drinking about a week. Sertralin is widely distributed into tissues and fluid fluids, through blood - brain and breast milk barriers.
The drug is linked to plasma proteins about 98%, mainly albumin and α1-acid glycoprotein.
Sertralin is metabolized in the liver, the main metabolite is N-Desmethylsertralin less active than Sertralin. But the relationship between plasma concentrations of sertralin and n-Desmethylsertralin with the treatment effect and/or toxicity of the drug has not been clearly defined. Sertralin is eliminated mainly in the form of metabolism of feces and urine with an equal approximate amount.
Sertralin waste time is about 25-26 hours and the waste sale time of N-Desmethylsertralin is about 62-104 hours.
In the elderly, the sale time may increase (about 36 hours). However, prolonged elimination is not clinically important and does not need to adjust the dose. Because the sertralin metabolizes strongly in the liver, the liver damage can affect the elimination of drugs, which should be cautious to use drugs for people with liver damage, with lower doses or fewer times.Sertralin's
pharmacokinetics is not affected by kidney damage.
Before taking Savi Sertraline 50 medicine treats depression, panic disturbance (3 blisters x 10 tablets)
How to use
Savi Sertraline 50 medicine for oral.
Should take medicine once a day in the morning or afternoon.
Can take medicine during or outside meals.
Avoid sudden stopping the drug. If you want to stop the drug, you must reduce the dose slowly for at least 1 to 2 weeks to reduce the risk of cessation syndrome.
If unpleasant symptoms occur after a decrease in the dose or after treatment stopped, it may be considered for the use of the given dose before. Then continue to reduce the dose but at a slower speed.
Dosage
Initial treatment dose
Depression and rapid obsession:
Sertralin should be used at a dose of 50 mg/day.
Panic disorders, stress disorders after injury and social obsession: Treatment should start at a dose of 25 mg/ day. After 1 week, the dose should be increased to 50 mg once a day. This dose has been shown to reduce the frequency of acute allowances, which is a characteristic of panic disorders at the beginning of treatment.
Dose adjustment:Patients who do not respond to a dose of 50 mg may obtain good results when increasing the dose. The dose changes should be conducted at a distance of at least 1 week, which can increase to a maximum of 200 mg/day. Dosage changes should not be done more than 1 time a week because the Sertralin's disposal time is 24 hours.
The beginning of treatment can be achieved within 7 days. However, it usually takes a longer period of time to get a clear treatment, especially in rapist obsessive disorders.
Dosage of maintenance treatment
Dosage during long -term treatment should be kept at the lowest level, then adjust the dose depending on the level of treatment.
Depression:
Long -term treatment may also be suitable to prevent relapse of depression. In most cases, the recommended doses to prevent depression relapse are similar to the dose used in treatment. Depression patients need to be treated for at least 6 months to ensure all the symptoms.
Panic disadvantages and rape obsessive disorders:
Maintain treatment should be evaluated regularly in these disorders because recurrent prevention has not been proven.
Children and teenagers are raped:
From 6 to 12 years old: Start 25 mg once a day. After 1 week, the dose can be increased to 50 mg once a day.
In case of less response to the dose of 50 mg, subsequent doses may increase in a period of several weeks if needed. The maximum dose is 200 mg per day. However, in general, children's body weight is often lower than adults, so they must consider when increasing the dose of over 50 mg. Dose change should not be done at a distance of less than 1 week.
Other objects
Children:
Effective when using Sertralin to treat depression in children has not been proven and there is no data on the use of Sertralin for children under 6 years old.
Elderly:
Be cautious when using Sertralin for the elderly because there is a risk of more sodium hypoglycemia.
Patients with liver failure:
Be cautious when using sertralin for people with liver disease. Dosage should be reduced or reduced the number of times used in patients with liver failure. Sertralin should not be used in cases of severe liver failure because there is no clinical data.
Patients with renal failure:
No dose adjustments in patients with renal failure.
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?
Acute poisoning
Symptoms:
acute dosage in unknown people.
Overdose often causes excessive increase in pharmacological effects and side effects of the drug. Common symptoms of overdose include: drowsiness, anxiety, nausea, vomiting, tachycardia, electrocardiogram changes, pupils. Some unwanted effects such as tachycardia, hypertension, high fever, red face, tremor of the heads have met in 1 child after taking the wrong serotonin, reacting like serotonin syndrome.
Management:
Sertralin has no specific antidote. Therefore, when overdose often treat symptoms and support treatment. If new poisoning, can cause vomiting.
If the patient is a coma or a seizure without a reflex, the stomach is lavely after the intubation is placed to avoid breathing in the stomach. Using activated carbon (can be coordinated with sorbitol) from the beginning or after causing vomiting and gastric lavage, need to maintain the patient's respiration, ventilation and oxygen breathing.
Methods of hemolysis, abdominal division, forced diuretic, blood transfusion are ineffective due to the large distribution of Sertralin and highly linked to protein.
Chronic poisoning
Symptoms:
There have been 1 case that has been notified with a cessation syndrome 2 days after stopping the drug suddenly. Manifestations of cessation syndrome: fatigue, abdominal cramps, memory damage and symptoms like flu, dizziness, tremor, tremor, sweating and loss of coordination, headache, drum drum ... These reactions are usually over within a few weeks later. To avoid this syndrome, it is necessary to stop Sertralin gradually.
Management:
Need to closely monitor patients with a history of drug addiction to detect signs of wrong dose or drug abuse (such as increasing dose due to greasy development, acts of finding drugs to take).
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
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 Savi Sertraline 50, you may experience unwanted effects (ADR).
Very common, (ADR> 1/10)
Common, (≥ 1/100 to
Central nervous system: depression, personality disorders, nightmares, anxiety, agitation, stress, sex reduction, grinding teeth, paresthesia, tremor, increased muscle tone, taste disorders, attention disorders, distraction. Uncommon, (≥ 1/1000 to Central nervous system: hallucinations, prone to aggression, refreshment, insensitivity, abnormal temperament, convulsions, non -active muscle contraction, abnormal coordination, hyperactivity, confusion, reduced sensation, language disorders, dizziness posture, fainting, migraine. Skin and subcutaneous tissue: edema around the eye hole, face edema, hemorrhage, hair loss, cold sweat, dry skin, itching, urticaria. Kidney and urinary tract: urinate, night urine, urinary retention, painful urination, urination disorders. Rare, (≥ 1/10,000 to Central nerve: Transfer disorders, drug dependence, psychological disorders, paranoia, suicidal thoughts or behaviors, sleepwalking, coma, dancing dance, movement disorders, sensitive, sensory disorders. Liver: Abnormal liver function. Skin and subcutaneous tissue: Dermatitis, puffiness, rash, abnormal hair structure. Kidney and urinary tract: Distant, urinary incontinence, slow urination. Surgery: vasodilation. Unknown frequency Thần kinh trung ương: Ác mộng, rối loạn vận động (bao gồm triệu chứng ngoại tháp, tăng động, tăng trương lực cơ, rối loạn trương lực, nghiến răng hoặc dáng đi bất thường), dấu hiệu và triệu chứng có liên quan đến hội chứng serotonin và hội chứng ác tính do dùng thuốc an thần kinh (kích động, lú lẫn, toát mồ hôi, tiêu chảy, sốt, tăng huyết áp, co cứng và nhịp tim nhanh), chứng đứng ngồi không yên và tâm thần bồn chồn, Brain vascular spasms (including recovery of cerebral vascular contraction syndrome and call-fleming syndrome). Hepatoma: Severe symptoms of liver disease (hepatitis, jaundice, liver failure). Skin and subcutaneous tissue: Stevens-Johnson syndrome and epidermal necrosis, angioedema, light sensitivity, skin reaction. Instructions on how to handle ADR ADRs are often seen in the first week or the first 2 weeks of treatment. ADR ratio increases when the dose increases. Prelopatic studies do not see Sertralin causing drugs and cessation syndrome after stopping. However, clinical symptoms show that cessation syndrome may occur after a few days of stopping the drug. About 15% of adults have to stop Sertralin in clinical trials because of the side effects of mind such as drowsiness, insomnia, struggle, tremor; Other neurological symptoms such as dizziness, headache; Digesting such as nausea, diarrhea, anorexia, fatigue, slow ejaculation. Cetamination syndrome (unexplained due to drugs) occurred below 0.5% has been reported in Sertralin treatment. is like other medications on other central nervous systems, so carefully assess the condition of the patient before taking Sertralin. If the patient has a history of medicine with a certain drug, when treatment needs to closely monitor the signs of drugs 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
Savi Sertraline 50 contraindications in the following cases:
Thận trọng khi sử dụng
Sự phát triển các hội chứng tiềm tàng đe dọa đến tính mạng như hội chứng serotonin (SS: Serotonin Syndrome) hay hội chứng ác tính thuốc an thần kinh (NMS: Neuroleptic Malignant Syndrome) đã được báo cáo khi dùng thuốc ức chế chọn lọc tái hấp thu serotonin (SSRI: Selective Serotonin Re-uptake InhiBitor), including sertralin.
The risk of serotonin syndrome or malignant syndrome when using SSRI drugs increases when used simultaneously with drugs that increase serotonin (including antidepressants acting on serotonin systems and triptan groups), drugs that reduce serotonin metabolism (including Monoamine inhibitors of oxidase such as methylene), antiviral drugs, dopamine drugs and dopamine drugs.
Serotonin syndrome symptoms include: Change of mind (such as stimulation, hallucinations, coma), unstable plant neurons (such as fast heartbeat, erratic blood pressure, high fever), neurological - muscular disorders (such as increased reflexes, loss of coordination) and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea).
In the most severe forms, Serotonin syndrome is like malignant syndrome: very high fever, muscle spasm, unstable plant nerves, rapid change of life function, mental state changes. The appearance of symptoms and signs of serotonin syndrome and malignant symptoms in patients.
switch between SSRIs, antidepressants and obsessive antidepressants: There are very few research that verifies the optimal time for the transformation of treatment from SSRI, antidepressants or other obsessive antidepressants to Sertralin. Should monitor and have caution assessment when conversion, especially from long -lasting drugs such as fluoxetin.
Simultaneous use of sertralin with other drugs enhances the neurotransmitter effect on the serotonin system such as tryptophan, fenfluramine, the owner of the 5-HT receptor, or the herbal medicine St. John’s World (Hypericum Perforatum) should be conducted carefully and should be avoided if possible due to the risk of pharmacological interaction.
There have been reports on cases that extend the QT interval and twisted when using sertralin, mainly occurring in patients at risk. Therefore, it is necessary to be cautious when using sertralin for patients with risk factors for extending the QT range.
Renect/Sangha has been reported at a small percentage of patients treated with antidepressants and other obsessive antidepressants, including Sertralin. Therefore, Sertralin must be used carefully for people with a history of manic and must be closely monitored. Sertralin must be stopped when the patient has a manic.
Mental symptoms can become worse in schizophrenia patients.
Epilepsy can occur during treatment with sertralin. Do not use Sertralin for patients with unstable epilepsy and controlled epilepsy patients should be carefully monitored. Sertralin should be stopped when the patient progresses epilepsy.
Due to depression patients or suicidal ideas or behavior, especially when they are first used, so they need to closely monitor the patient until the disease is much better, and start the low doses to reduce the risk of overdose.
Do not use Servalin for children and teenagers under 18 years old, except for patients with obsessive obsessive disorders aged 6-17.
Behavioral behavior (trying to commit suicide and suicide thoughts), and hostility (mainly fighting, opposing and angry) are more observed in more frequent clinical trials in children and adolescents treated with antidepressants compared to those who are treated with placebo. Based on clinical needs, the treatment is still implemented. At that time, the patient should be carefully monitored the appearance of the above symptoms.
There have been reports on abnormal bleeding on the skin (bruises, hemorrhage) or other hemorrhage phenomena such as gastrointestinal bleeding or gynecological, including hemorrhage leading to death when taking SSRI. Therefore, it is necessary to be cautious in patients using SSRI, especially simultaneously used with drugs that affect platelet function (anticoagulant drugs, non -typical sedatives and phenothiazin, 3 -ring antidepressants, acetylsalicylic acid and nonsteroidal anti -inflammatory drugs) in patients with a history of bleeding disorders.
Hemorrhage reduction may occur when treated with sertralin. In many cases, sodium hypoglycemia is caused by inappropriate anti -urinary hormone syndrome (SIADH: Syndrome of inappropriate antidiuretic hormone secretion). There have been reports of serum sodium levels lower than 110 mmol/1.
The elderly, who are taking diuretics or drugs that reduce the volume of circulatory due to other risks. Sertralin should be considered for patients with symptoms of sodium hypoglycemia and proper treatment. Signs and symptoms of sodium hypoglycemia include: headache, poor concentration, memory loss, confusion, weakness and instability can lead to depression. Signs and more severe symptoms and/or acute include hallucinations, fainting, convulsions, coma, respiratory extraction and death.
Using Sertralin is involved in the progression of standing still, usually occurs during the first few weeks of treatment. If the dose increases can be harmful.
In patients with diabetes, SSRI treatment can change blood sugar control. Adjusting insulin and/or oral medications that reduce blood sugar should be done if necessary.
SSRIs like Sertralin can affect the size of the copper, dilating the pupils. The effect of dilating the pupils can cause an angle narrowing leading to increased intraocular pressure and glaucom closed angle, especially in the patient who tends to be before. Therefore, it is advisable to use sertralin carefully in patients with a closed angle Glaucom or a history of Glaucom.
Sertralin can cause anorexia and weight loss, so it is necessary to be cautious when used for mild weight patients.
Certificate syndrome usually occurs when stopping using Sertralin, especially sudden stopping. In clinical trials, the rate of cessation syndrome in patients stopped using sertralin compared to patients continued to treat with sertralin is 23/12.
The risk of cessation syndrome depends on a number of factors such as use time, treatment dose and dose reduction rate. Dizziness, sensory disorders (including abnormalities), sleep disorders (insomnia, nightmares), agitation or anxiety, nausea and/or vomiting, tremor and headache are common and often mild to medium reactions.
However, in some patients, the degree may be worse. Symptoms occur within the first few days of stopping treatment, but very few reports on symptoms when the patient accidentally forgot the dose. Usually these symptoms are self-relieved and usually within 2 weeks, but some patients may last (2-3 months or more). Therefore, when stopping treatment should reduce the dose slowly for a few weeks or months, depending on the needs of the patient.
Due to the presence of lactose in preparations, patients with rare genetic disorders in glucose tolerance, lactase lactase deficiency or glucose-galactose absorption disorders should not be used.
The ability to drive and operate machinery
although Sertralin has little effect that causes drowsiness than other antidepressants, Nhung still has to be cautious with the train driver or operating machinery and especially when used simultaneously with central neurological inhibitors.
Pregnancy
There is no research document on using sertralin for pregnant women. However, due to the drug through the placenta, it can cause unwanted effects on the fetus's nerves. Therefore, it is not recommended to use, need to consider benefits and risks.
The period of breastfeeding
Sertralin is distributed into breast milk, so it can cause unwanted effects for breastfed babies. Therefore, it is not recommended for women who are breastfeeding, need to consider benefits and risks.
Interactive drug
Monoamine inhibitors Oxidase
Do not use Sertralin combination with Maoi drugs including non -recovery monoamine inhibitors (Selegilin), selective inhibitors with Monoamine Oxidase recovery (Moclobemid), unsatisfactory inhibitors with recovery of monoamine oxidase (Linezolid antibiotic).
Do not use Sertralin at least 7 days before starting treatment and at least 14 days after stopping treatment with these drugs.
Serious harmful effects occur for patients when they stop using Maoi (such as Methylene Blue) and start using Sertralin or stop using Sertralin before starting to use Maoi has been reported. Symptoms include: Run, muscle vibration, foul tissue, nausea, vomiting, blushing, dizziness and high body temperature with matches similar to malignant syndrome of neuroleptics, epilepsy and eventually death.
pimozid
Pimozid concentration increased to about 35% proven in a test with a single low -dose pimozid (2 mg). This increase is not related to the change of electrocardiogram. While the mechanism of the interaction is not well known, because Pimozid has a narrow therapy, so contraindicated to share sertralin with pimozid.
Central and alcoholic inhibitors
Simultaneous use with sertralin 200 mg/day does not increase the effects of alcohol, carbamazepin, haloperidol or phenytoin on cognitive and psychological ability in healthy people; However, it is not recommended to simultaneously use Sertralin and alcohol.
Medicines on other serotonin systems
Be careful when taking medicine with fentanyl (used for chronic anesthesia and treatment of chronic pain), other acting drugs on other serotonin systems (including antidepressant drugs acting on Serotonin system, triptan group) and addictive drugs.
The drug extends the range of qt
The risk of extending the range of QT and/or ventricular arrhythmias (torsion) can be increased when shared with the drugs that extend the QT (such as some anti -psychotic and antibiotic drugs).
lithium
In a place where placebo -verified tests in ordinary volunteers, simultaneous use of sertralin with lithium does not significantly change lithium pharmacokinetics but increases the proportion of patients trembling compared to the placebo group, indicates the ability to interact with the pharmacological force between these two drugs. When using Sertralin simultaneously with lithium, patients should be properly monitored.
phenytoin
Verified tests in ordinary volunteers suggest that long -term use of Sertralin 200 mg/day does not significantly inhibit the transformation of phenytoin clinically. However, some cases have shown an increase in phenytoin concentration in patients using Sertralin, so it is recommended to monitor Phenytoin concentration in blood when starting treatment with sertralin and adjusting phenytoin dose accordingly. In addition, simultaneous use with phenytoin may be the cause of decreased plasma sertralin levels. Other CYP3A4 enzyme induction cannot be excluded such as Phenobarbital, Carbamazepin, St John’s Wort, Rifampicin may cause a decrease in sertralin in plasma.
Triptan group
There are very few reports that describe patients with weakness, increase reflexes, lose the ability to coordinate, confuse, anxiety and agitation after using Sertralin and Sumatriptan. Symptoms of serotonin syndrome can also occur when used with drugs in the same triptan group. Appropriate patient monitoring should be taken if clinically required to treat Sertralin and Sumatriptan.
warfarin
Simultaneous use of Sertralin 200 mg daily with warfarin causes small amounts but statistically significant about prothrombin time that in a few cases may cause Inr value imbalance (INR: International Normalized Ratio). Therefore, prothrombin should be carefully monitored when starting or ending treatment with sertralin.
digoxin, atenolol, cimetidine
Simultaneous use of sertralin with cimetidine causes significantly reducing sertralin's clearance. The clinical significance of these changes is not known. Sertralin does not affect the ability to inhibit the Adrenergic receptor of Atenolol. No interaction between sertralin daily daily when used with digoxin.
Medicines affect platelet function
The risk of bleeding may increase when used with drugs that act on the function of platelets (nonsteroidal anti -inflammatory drugs, acetylsalicylic and ticlopidin) or other drugs that increase the risk of bleeding when used simultaneously with SSRI, including sertralin.
neurotransmitter
SSRIs can reduce cholinesterase activity in plasma, leading to a prolongation of mental inhibition effects of Mivacurium or other neural blockers.
Metabolic drug by cytochrom P450
Sertralin acts as a light-medium-light CYP2D6 inhibitor. Long-term use of Sertralin at a dose of 50 mg daily shows a moderate increase (23%-37%on average) of the concentration of Despiramin (ISOENZYM CYP2D6 active active substance) in a constant state in plasma. Clinical related interactions can occur with other metabolized substances by CYP2D6 with narrow treatment index such as anti -arrhythmic drugs Group 1C (Propafenon and Flecainid), 3 -round antidepressants and typical anti -psychotic disorders, especially at higher sertralin doses.
Sertralin does not inhibit CYP3A4, CYP2C9, CYP2C19 and CYP1A2 to a clinical significance. This has been confirmed by interactive studies on Vivo with metabolites by CYP3A4 (endogenous cortisol, carbamazepin, terfenadin, alprazolam), CYP2C19 (diazepam), CYP2C9 (Tolbutamid, Glibenclamid and Phenytoin). In vitro studies have shown that sertralin has little or incapable of inhibiting CYP1A2.
Sertralin simultaneously simultaneously use Sertralin with strong CYP3A4 inhibitors (Protease inhibitors, ketoconazol, iTraconazol, Posaconazole, Voriconazole, Clarithromycin, Telithromycin and Nefazodon) or with medium CYP3A4 inhibitors (Aprucitant, erythromycin, fluconil and veraponil, veraponil and veraponil, verapamil and veraponils Diltiazem) may increase the concentration of sertralin. Strong CYP3A4 inhibitors should be avoided during treatment with sertralin.Sertralin plasma concentration when used with slow metabolites CYP2C19 increases by 50% compared to when used with fast metabolites. It is also impossible to exclude interactive with strong CYP2C19 inhibitors such as omeprazol, lansoprazol, pantoprazol, rabeprazol, fluoxetin, fluvoxamine.
Storage
In a dry place, avoid light, temperature below 30 ° C.
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