Abacavir Oral Solution

Name: Abacavir Oral Solution

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Chest pain or pressure.
  • Low mood (depression).
  • Very bad dizziness or passing out.
  • Mouth sores.
  • Muscle pain or weakness.
  • Swollen gland.
  • A burning, numbness, or tingling feeling that is not normal.
  • Swelling.
  • Change in body fat.
  • This medicine may help the immune system work. If you have an infection that you did not know you had, it may show up when you take abacavir oral solution. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start this medicine.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Dosage & administration

Screening for HLA-B*5701 Allele prior to Starting Abacavir

Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir [see Boxed Warning, Warnings and Precautions (5.1)].

Recommended Dosage for Adults patients

The recommended dosage of abacavir for adults is 600 mg daily, administered orally as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.

Recommended Dosage for Pediatric


The recommended dosage of Abacavir Oral Solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg per kg orally twice daily or 16 mg per kg orally once-daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents.
Abacavir is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing abacavir tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow abacavir tablets, the oral solution formulation should be prescribed. The recommended oral dosage of abacavir tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Abacavir Scored Tablets in Pediatric Patients


Weight
(Kg)
Once-daily Dosing Regimena
Twice-daily Dosage Regimen
AM Dose
PM Dose
Total Daily Dose
14 to <20
1 tablet (300 mg)
½  tablet (150 mg)
½  tablet (150 mg)
300 mg
≥20 to <25
1½ tablets (450 mg)
½  tablet (150 mg)
1 tablet (300 mg)
450 mg
≥25
2 tablets (600 mg)
1 tablet (300 mg)
1 tablet (300 mg)
600 mg

a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies (14.2)].




Recommended Dosage for Patients with Hepatic Impairment


The recommended dose of abacavir in patients with mild hepatic impairment (Child-Pugh Class A) is 200 mg twice daily. To enable dose reduction, Abacavir Oral Solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, abacavir is contraindicated in these patients.

Dosage forms & strengths

Abacavir Oral Solution, USP contains 20 mg per mL of abacavir as abacavir sulfate, USP. The solution is clear yellowish, strawberry-banana flavored liquid filled in 250 cc HDPE opaque bottles.

Drug Interactions

Methadone


In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy with 600 mg of abacavir twice daily (twice the currently recommended dose), oral methadone clearance increased [see Clinical Pharmacology (12.3)]. This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.

Overdosage


There is no known specific treatment for overdose with abacavir. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.

Clinical Studies

Adults trials


Therapy-Naive Adults
CNA30024 was a multicenter, double-blind, controlled trial in which 649 HIV-1-infected, therapy-naive adults were randomized and received either abacavir (300 mg twice daily), lamivudine (150 mg twice daily), and efavirenz (600 mg once daily); or zidovudine (300 mg twice daily), lamivudine (150 mg twice daily), and efavirenz (600 mg once daily). The duration of double-blind treatment was at least 48 weeks. Trial participants were male (81%), white (51%), black (21%), and Hispanic (26%). The median age was 35 years; the median pretreatment CD4+ cell count was 264 cells per mm3, and median plasma HIV-1 RNA was 4.79 log10 copies per mL. The outcomes of randomized treatment are provided in Table 7.
Table 7. Outcomes of Randomized Treatment through Week 48 (CNA30024)

Outcome
Abacavir plus Lamivudine plus Efavirenz
(n = 324)
Zidovudine plus Lamivudine plus Efavirenz
(n = 325)
Respondera
69% (73%)
69% (71%)
Virologic failuresb
6%
4%
Discontinued due to adverse reactions
14%
16%
Discontinued due to other reasonsc
10%
11%

a Subjects achieved and maintained confirmed HIV-1 RNA less than or equal to 50 copies per mL (less than 400 copies per mL) through Week 48 (Roche AMPLICOR Ultrasensitive HIV-1 MONITOR® standard test 1.0 PCR).
b Includes viral rebound, insufficient viral response according to the investigator, and failure to achieve confirmed less than or equal to 50 copies per mL by Week 48.
c Includes consent withdrawn, lost to follow up, protocol violations, those with missing data, clinical progression, and other.
After 48 weeks of therapy, the median CD4+ cell count increases from baseline were 209 cells per mm3 in the group receiving abacavir and 155 cells per mm3 in the zidovudine group. Through Week 48, 8 subjects (2%) in the group receiving abacavir (5 CDC classification C events and 3 deaths) and 5 subjects (2%) on the zidovudine arm (3 CDC classification C events and 2 deaths) experienced clinical disease progression.
CNA3005 was a multicenter, double-blind, controlled trial in which 562 HIV-1-infected, therapy-naive adults were randomized to receive either abacavir (300 mg twice daily) plus COMBIVIR® (lamivudine 150 mg/zidovudine 300 mg twice daily), or indinavir (800 mg 3 times a day) plus COMBIVIR twice daily. The trial was stratified at randomization by pre-entry plasma HIV-1 RNA 10,000 to 100,000 copies per mL and plasma HIV-1 RNA greater than 100,000 copies per mL. Trial participants were male (87%), white (73%), black (15%), and Hispanic (9%). At baseline the median age was 36 years; the median baseline CD4+ cell count was 360 cells per mm3, and median baseline plasma HIV-1 RNA was 4.8 log10 copies per mL. Proportions of subjects with plasma HIV-1 RNA less than 400 copies per mL (using Roche AMPLICOR HIV-1 MONITOR Test) through 48 weeks of treatment are summarized in Table 8.
Table 8. Outcomes of Randomized Treatment through Week 48 (CNA3005)

Outcome
Abacavir plus Lamivudine/Zidovudine
(n = 262)
Indinavir plus Lamivudine/Zidovudine
(n = 265)
Respondera
49%
50%
Virologic failureb
31%
28%
Discontinued due to adverse reactions
10%
12%
Discontinued due to other reasonsc
11%
10%

a Subjects achieved and maintained confirmed HIV-1 RNA less than 400 copies per mL.
b Includes viral rebound and failure to achieve confirmed less than 400 copies per mL by Week 48.
c Includes consent withdrawn, lost to follow up, protocol violations, those with missing data, clinical progression, and other.
Treatment response by plasma HIV-1 RNA strata is shown in Table 9.
Table 9. Proportions of Responders through Week 48 by Screening Plasma HIV-1 RNA Levels (CNA3005)

Screening HIV-1 RNA
(copies/mL)
Abacavir plus
Lamivudine/Zidovudine
 (n = 262)
Indinavir plus Lamivudine/Zidovudine
 (n = 265)
<400 copies/mL
n
<400 copies/mL
n
≥10,000 - ≤100,000 >100,000
50%
48%
166
96
48%
52%
165
100

In subjects with baseline viral load greater than 100,000 copies per mL, percentages of subjects with HIV-1 RNA levels less than 50 copies per mL were 31% in the group receiving abacavir versus 45% in the group receiving indinavir.
Through Week 48, an overall mean increase in CD4+ cell count of about 150 cells per mm3 was observed in both treatment arms. Through Week 48, 9 subjects (3.4%) in the group receiving abacavir (6 CDC classification C events and 3 deaths) and 3 subjects (1.5%) in the group receiving indinavir (2 CDC classification C events and 1 death) experienced clinical disease progression.
CNA30021 was an international, multicenter, double-blind, controlled trial in which 770 HIV-1-infected, therapy-naive adults were randomized and received either abacavir 600 mg once daily or abacavir 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily. The double-blind treatment duration was at least 48 weeks. Trial participants had a mean age of 37 years; were male (81%), white (54%), black (27%), and American Hispanic (15%). The median baseline CD4+ cell count was 262 cells per mm3 (range: 21 to 918 cells per mm3) and the median baseline plasma HIV-1 RNA was 4.89 log10 copies per mL (range: 2.60 to 6.99 log10 copies per mL).
The outcomes of randomized treatment are provided in Table 10.
Table  10. Outcomes of Randomized Treatment through Week 48 (CNA30021)



Outcome


Abacavir 600 mg q.d. plus EPIVIR® plus Efavirenz
(n = 384)


Abacavir 300 mg b.i.d. plus EPIVIR plus Efavirenz
(n = 386)

Respondera

64% (71%)

65% (72%)

Virologic failureb

11% (5%)

11% (5%)

Discontinued due to adverse reactions

13%

11%

Discontinued due to other reasonsc

11%

13%

a Subjects achieved and maintained confirmed HIV-1 RNA less than 50 copies per mL (less than 400 copies per mL) through Week 48 (Roche AMPLICOR Ultrasensitive HIV-1 MONITOR standard test version 1.0).
b Includes viral rebound, failure to achieve confirmed less than 50 copies per mL (less than 400 copies per mL) by Week 48, and  insufficient viral load response.
c Includes consent withdrawn, lost to follow up, protocol violations, clinical progression, and other.
After 48 weeks of therapy, the median CD4+ cell count increases from baseline were 188 cells per mm3 in the group receiving abacavir 600 mg once daily and 200 cells per mm3 in the group receiving abacavir 300 mg twice daily. Through Week 48, 6 subjects (2%) in the group receiving abacavir 600 mg once daily (4 CDC classification C events and 2 deaths) and 10 subjects (3%) in the group receiving abacavir 300 mg twice daily (7 CDC classification C events and 3 deaths) experienced clinical disease progression. None of the deaths were attributed to trial medications.

Pediatric Trials


Therapy-Experienced Pediatric Subjects
CNA3006 was a randomized, double-blind trial comparing abacavir 8 mg per kg twice daily plus lamivudine 4 mg per kg twice daily plus zidovudine 180 mg per m2 twice daily versus lamivudine 4 mg per kg twice daily plus zidovudine 180 mg per m2 twice daily. Two hundred and five therapy-experienced pediatric subjects were enrolled: female (56%), white (17%), black (50%), Hispanic (30%), median age of 5.4 years, baseline CD4+ cell percent greater than 15% (median = 27%), and median baseline plasma HIV-1 RNA of 4.6 log10 copies per mL. Eighty percent and 55% of subjects had prior therapy with zidovudine and lamivudine, respectively, most often in combination. The median duration of prior nucleoside analogue therapy was 2 years. At 16 weeks the proportion of subjects responding based on plasma HIV-1 RNA less than or equal to 400 copies per mL was significantly higher in subjects receiving abacavir plus lamivudine plus zidovudine compared with subjects receiving lamivudine plus zidovudine, 13% versus 2%, respectively. Median plasma HIV-1 RNA changes from baseline were -0.53 log10 copies per mL in the group receiving abacavir plus lamivudine plus zidovudine compared with -0.21 log10 copies per mL in the group receiving lamivudine plus zidovudine. Median CD4+ cell count increases from baseline were 69 cells per mm3 in the group receiving abacavir plus lamivudine plus zidovudine and 9 cells per mm3 in the group receiving lamivudine plus zidovudine.
Once-Daily Dosing
ARROW (COL105677) was a 5-year randomized, multicenter trial which evaluated multiple aspects of clinical management of HIV-1 infection in pediatric subjects. HIV-1–infected, treatment-naïve subjects aged 3 months to 17 years were enrolled and treated with a first-line regimen containing abacavir and lamivudine, dosed twice daily according to World Health Organization recommendations. After a minimum of 36 weeks of treatment, subjects were given the option to participate in Randomization 3 of the ARROW trial, comparing the safety and efficacy of once-daily dosing with twice-daily dosing of abacavir and lamivudine, in combination with a third antiretroviral drug, for an additional 96 weeks. Of the 1,206 original ARROW subjects, 669 participated in Randomization 3. Virologic suppression was not a requirement for participation at baseline for Randomization 3 (following a minimum of 36 weeks of twice-daily treatment), 75% of subjects in the twice-daily cohort were virologically suppressed compared with 71% of subjects in the once-daily cohort.
The proportions of subjects with HIV-1 RNA less than 80 copies per mL through 96 weeks are shown in Table 11. The differences between virologic responses in the two treatment arms were comparable across baseline characteristics for gender and age.
Table 11. Virologic Outcome of Randomized Treatment at Week 96a (ARROW Randomization 3)

Outcome
Abacavir plus Lamivudine Twice-Daily Dosing
(n = 333)
Abacavir plus Lamivudine
Once-daily Dosing
 (n = 336)
HIV-1 RNA <80 copies/mLb
70%
67%
HIV-1 RNA ≥80 copies/mLc
28%
31%
No virologic data
 
 
Discontinued due to adverse event or death
1%
<1%
Discontinued study for other reasonsd
0%
<1%
Missing data during window but on study
1%
1%

a  Analyses were based on the last observed viral load data within the Week 96 window.
b  Predicted difference (95% CI) of response rate is -4.5% (-11% to 2%) at Week 96.
c  Includes subjects who discontinued due to lack or loss of efficacy or for reasons other than an adverse event or death, and had a viral load value of greater than or equal to 80 copies per mL, or subjects who had a switch in background regimen that was not permitted by the protocol.
d Other includes reasons such as withdrew consent, loss to follow-up, etc. and the last available HIV-1 RNA less than 80 copies per mL (or missing).


Medication guide


Abacavir Oral Solution
(ah-BAH-kah-veer)

What is the most important information I should know about Abacavir Oral Solution?
Abacavir can cause serious side effects, including:
• Serious allergic reaction (hypersensitivity reaction) that can cause death have happened with Abacavir Oral Solution and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation.
If you get a symptom from 2 or more of the following groups while taking Abacavir Oral Solution, call your healthcare provider right away to find out if you should stop taking Abacavir Oral Solution.


 
Symptom(s)
Group 1
Fever
Group 2
Rash
Group 3
Nausea, vomiting, diarrhea, abdominal (stomach area) pain
Group 4
Generally ill feeling, extreme tiredness, or achiness
Group 5
Shortness of breath, cough, sore throat

A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times.
If you stop Abacavir Oral Solution because of an allergic reaction, never take Abacavir Oral Solution or any other abacavir-containing medicine (EPZICOM®, TRIUMEQ®, and TRIZIVIR®) again.
• If you have an allergic reaction, dispose of any unused Abacavir Oral Solution. Ask your pharmacist how to properly dispose of medicines.
• If you take Abacavir Oral Solution or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life-threatening symptoms that may include very low blood pressure or death.
• If you stop Abacavir Oral Solution for any other reason, even for a few days, and you are not allergic to abacavir, talk with your healthcare provider before taking it again. Taking Abacavir Oral Solution again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.
If your healthcare provider tells you that you can take Abacavir Oral Solution again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.
• Build-up of acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take Abacavir Oral Solution. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
• feel very weak or tired                                    •    feel cold, especially in your arms and legs
• unusual (not normal) muscle pain                  •    feel dizzy or light-headed
• trouble breathing                                            •    have a fast or irregular heartbeat
• stomach pain with nausea and vomiting
• Serious liver problems can happen in people who take abacavir. In some cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take abacavir. Call your healthcare provider right away if you have any of the following signs of liver problems:
• your skin or the white part of your eyes turns yellow (jaundice)   • loss of appetite for several days or longer
• dark or "tea-colored" urine                                                            • nausea
• light-colored stools (bowel movements)                                        • pain, aching, or tenderness on the right side of your stomach area
You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking nucleoside analogue medicines for a long time.
What is Abacavir Oral Solution?
Abacavir Oral Solution is a prescription HIV-1 (Human Immunodeficiency Virus type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
The safety and effectiveness of abacavir has not been established in children under 3 months of age.
When used with other antiretroviral medicines to treat HIV-1 infection, Abacavir Oral Solution may help:
• reduce the amount of HIV-1 in your blood. This is called “viral load”.
• increase the number of CD4+ (T) cells in your blood, that help fight off other infections.
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
Abacavir does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.
Who should not take Abacavir Oral Solution?
Do not take Abacavir Oral Solution if you:
• have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with abacavir.
• are allergic to abacavir or any of the ingredients in Abacavir Oral Solution. See the end of this Medication Guide for a complete list of ingredients in Abacavir Oral Solution.
• have liver problems.
What should I tell my healthcare provider before taking Abacavir Oral Solution?
Before you take Abacavir Oral Solution, tell your healthcare providers if you:
• have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
• have or have had liver problems, including hepatitis B or C virus infection.
• have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
• drink alcohol or take medicines that contain alcohol.
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take abacavir.
• You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with abacavir. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with abacavir. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take abacavir with other medicines.
 Tell your healthcare provider if you take:
• any other medicine to treat HIV-1
• methadone
How should I take Abacavir Oral Solution?
• Take Abacavir Oral Solution exactly as your healthcare provider tells you.
• Do not change your dose or stop taking Abacavir Oral Solution without talking with your healthcare provider. If you miss a dose of Abacavir Oral Solution, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
• Stay under the care of a healthcare provider while taking abacavir.
• Abacavir Oral Solution may be taken with or without food.
• For children aged 3 months and older, your healthcare provider will prescribe a dose of Abacavir Oral Solution based on your child’s body weight.
• Do not run out of abacavir. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run out, get more from your healthcare provider or pharmacy.
• If you take too much Abacavir Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of Abacavir Oral Solution?
• Abacavir can cause serious side effects including:
• See "What is the most important information I should know about Abacavir Oral Solution?"
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when your start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new  symptoms after you start taking Abacavir Oral Solution.
• Changes in body fat can happen in people who take HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir may increase your risk of heart attack.
The most common side effects of abacavir in adults include:
• nausea                                   • tiredness
• headache                               • vomiting
• generally not feeling well       • bad dreams or sleep problems
The most common side effects of abacavir in children include:
• fever and chills      • rash
• nausea                  • ear, nose, or throat infections
• vomiting 
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of abacavir. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Abacavir Oral Solution?
• Store Abacavir Oral Solution at room temperature, between 20° to 25°C (68° to 77°F).
• Do not freeze Abacavir Oral Solution. You may store Abacavir Oral Solution in a refrigerator.
Keep Abacavir Oral Solution and all medicines out of the reach of children.
General information for safe and effective use of abacavir
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir for a condition for which it was not prescribed. Do not give abacavir to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about abacavir that is written for healthcare professionals.
What are the ingredients in Abacavir Oral Solution?
Active ingredient: abacavir sulfate USP
Inactive ingredients: anhydrous citric acid, methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), noncrystallizing sorbitol solution, strawberry and banana flavors and water.

All brands listed are trademarks of their respective owners and are not trademarks of the Hetero Labs Limited.

Manufactured for:





Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854


Manufactured by:
HETERO LABS LIMITED
22-110, I.D.A., Jeedimetla,                                   
Hyderabad – 500 055, India.  


This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 08/2017

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