"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
(Hydrocodone Bitartrate and Acetaminophen) Oral Solution 10 mg/300 mg per15 mL
ZOLVIT™ (pronounced ZOLV-it) is used to relieve moderate to moderately severe pain. You should not take ZOLVIT™ if you are allergic to hydrocodone or acetaminophen. The most common side effects of ZOLVIT™ are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
ZOLVIT™ is an analgesic used to relieve moderate to moderately severe pain. ZOLVIT™ is a combination product containing hydrocodone (hye-droe-KO-done) bitartrate and acetaminophen (a-seat-a-MIN-oh-fen). Hydrocodone is a narcotic pain reliever and a cough suppressant. Acetaminophen is a non-narcotic pain reliever and fever reducer. A narcotic analgesic and acetaminophen used together may provide better pain relief than either product used alone. If you have any questions, please call your doctor or pharmacist.
- Do not take this drug if you have allergies or unusual reactions to narcotic pain relievers or acetaminophen because it is likely that you may also be allergic to ZOLVIT™.
- This product may inhibit your mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while you are taking this product.
- This medicine may not be right for you. Check with your doctor or pharmacist,
- are pregnant.
- are nursing.
- are taking other medications: narcotic pain relievers; allergy medicines; antidepressant medicines; acetaminophen-containing medicines or other medicines that cause central nervous system depression, including alcohol.
- have other medical problems: a history of drug or alcohol abuse; recent head injury; emphysema, asthma, or other chronic lung disease; liver disease, kidney disease; underactive thyroid, Addison's disease, enlarged prostate or difficulty urinating.
Take this medicine as directed by your doctor. Do not share it with anyone else. This medicine can cause drug dependence and has the potential for abuse. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you think that this medicine is networking properly after taking it for some time, do not increase the dose. Check with your doctor or pharmacist.
The dose of this medication will be different for different patients. Follow the directions provided by your doctor. The following information includes only the average doses of this medication. If your dose is different, do not change doses unless your doctor tells you to do so.
|BODY WEIGHT||APPROXIMATE AGE||DOSE every 4 to 6 hours||MAXIMUM TOTAL DAILY DOSE (6 doses per day)|
|12 to 15 kg (27 to 34 Ibs.)||2 to 3 years||2.8 mL (approx. ½ teaspoonful)||16.8 mL (approx. 3 1/4 teaspoonfuls)|
|16 to 22 kg (35 to 50 Ibs.)||4 to 6 years||3.75 mL (approx. 3/4 teaspoonful)||22.5 mL (approx. 4½ teaspoonfuls)|
|23 to 31 kg (51 to 69 Ibs.)||7 to 9 years||5.6 mL (approx. 1 teaspoonful)||33.6 mL (approx. 6 ½ teaspoonfuls)|
|32 to 45 kg (70 to 100 Ibs.)||10to13years||7.5 mL (approx. 1½ teaspoonful)||45 mL (approx. 9 teaspoonfuls)|
|46 kg and up (101 Ibs. and up)||14 years to adult||11.25 mL (approx. 2 1/4 teaspoonfuls)||67.5 mL (approx. 13½ teaspoonfuls)|
It is very important that ZOLVIT™ be dosed accurately. A household teaspoon or tablespoon is not an accurate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured.
Since a household teaspoon is not accurate and can be mixed-up with a tablespoon (which can cause overdosage), it is strongly recommended that you obtain and use a proper measuring device. Ask your doctor or pharmacist for help to find a dropper that can measure the needed dose properly and ask for help if you do not understand how to use the dropper.
- To avoid a possible overdose, it is important that you do not take more than a single dosage at one time, or that you don't take doses at intervals less than 4 hours apart.
- If you miss taking a dose of ZOLVIT™, take it as soon as you remember. However, make sure to wait at least 4 hours before taking your next dose.
- If you missed taking a dose, and it is almost time for your next dose, skip the missed dose and take your medicine as scheduled.
- Do not double the prescribed dose.
Possible Side Effects
Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light- headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting.
Call your doctor if these effects continue or are bothersome.
Side effects not listed above may sometimes occur. If you notice any other effects, check with your doctor.
- Keep out of reach of children.
- Store at room temperature (protect from heat, do not refrigerate).
- Keep in original labeled bottle.
- Discard medicines that are old or no longer needed.
- Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have token more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use it for another condition or give the drug to others.
- This leaflet provides a summary of information about ZOLVIT™. If you have any questions or concerns, or want more information about ZOLVIT™, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about ZOLVIT™ that is written for health professionals that you can ask to read.
Last reviewed on RxList: 8/15/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Zolvit Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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