Mercaptopurina Refasa may be available in the countries listed below.
Mercaptopurine is reported as an ingredient of Mercaptopurina Refasa in the following countries:
International Drug Name Search
Ixor may be available in the countries listed below.
Roxithromycin is reported as an ingredient of Ixor in the following countries:
International Drug Name Search
Terablock may be available in the countries listed below.
Terazosin hydrochloride (a derivative of Terazosin) is reported as an ingredient of Terablock in the following countries:
International Drug Name Search
Coronamole may be available in the countries listed below.
Dipyridamole is reported as an ingredient of Coronamole in the following countries:
International Drug Name Search
Generic Name: ofloxacin ophthalmic (oh FLOX a sin off THAL mik)
Brand Names: Ocuflox
Ofloxacin ophthalmic is an antibiotic.
Ofloxacin ophthalmic is used to treat bacterial infections of the eyes.
Ofloxacin ophthalmic may also be used for purposes other than those listed in this medication guide.
Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.
If you wear contact lenses, ask your doctor if you should wear them during treatment. Ofloxacin ophthalmic can cause the development of crystals on contact lenses. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.
Use ofloxacin ophthalmic eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Wash your hands before using the eyedrops.
To apply the eyedrops:
Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.
If you are using ofloxacin ophthalmic to treat a corneal ulcer, you may notice a whitish buildup on the ulcer. This means that the medication is working; it is not a harmful development.
Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.
An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.
If you wear contact lenses, ask your doctor if you should wear them during treatment. Ofloxacin ophthalmic can cause the development of crystals on contact lenses. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.
Serious side effects are not expected to occur during treatment with this medication.
If you are using ofloxacin ophthalmic to treat a corneal ulcer, you may notice a whitish buildup on the ulcer. This means that the medication is working; it is not a harmful development.
More commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling or crusting, a bad taste in your mouth, tearing, or sensitivity to light may occur.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drugs other than those listed here may also interact with ofloxacin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
See also: Ocuflox side effects (in more detail)
Artridol may be available in the countries listed below.
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Artridol in the following countries:
International Drug Name Search
Gabbrocet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Paracetamol is reported as an ingredient of Gabbrocet in the following countries:
International Drug Name Search
Nippas Calcium may be available in the countries listed below.
Aminosalicylic Acid calcium (a derivative of Aminosalicylic Acid) is reported as an ingredient of Nippas Calcium in the following countries:
International Drug Name Search
Oxatokey may be available in the countries listed below.
Oxatomide is reported as an ingredient of Oxatokey in the following countries:
International Drug Name Search
Zomigon may be available in the countries listed below.
Zolmitriptan is reported as an ingredient of Zomigon in the following countries:
International Drug Name Search
Climatrol HT Continuo may be available in the countries listed below.
Estrogens, conjugated is reported as an ingredient of Climatrol HT Continuo in the following countries:
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Climatrol HT Continuo in the following countries:
International Drug Name Search
Cisplatino Pharmacia may be available in the countries listed below.
Cisplatin is reported as an ingredient of Cisplatino Pharmacia in the following countries:
International Drug Name Search
Fluifort may be available in the countries listed below.
Carbocisteine lysine salt (a derivative of Carbocisteine) is reported as an ingredient of Fluifort in the following countries:
International Drug Name Search
Biperideno Vannier may be available in the countries listed below.
Biperiden is reported as an ingredient of Biperideno Vannier in the following countries:
International Drug Name Search
Upsavit Vitamin C may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Upsavit Vitamin C in the following countries:
International Drug Name Search
Donadin may be available in the countries listed below.
Povidone-Iodine is reported as an ingredient of Donadin in the following countries:
International Drug Name Search
Ostac may be available in the countries listed below.
Clodronic Acid is reported as an ingredient of Ostac in the following countries:
Clodronic Acid disodium tetrahydrate (a derivative of Clodronic Acid) is reported as an ingredient of Ostac in the following countries:
International Drug Name Search
Spassirex may be available in the countries listed below.
Phloroglucinol dihydrate (a derivative of Phloroglucinol) is reported as an ingredient of Spassirex in the following countries:
International Drug Name Search
Terricil may be available in the countries listed below.
Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Terricil in the following countries:
International Drug Name Search
Generic Name: bepotastine ophthalmic (BEP oh TAS teen off THAL mik)
Brand Names: Bepreve
Bepotastine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of itching or watery eyes.
Bepotastine ophthalmic may also be used for other purposes not listed in this medication guide.
Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
To apply the eye drops:
Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
An overdose of bepotastine ophthalmic is not likely to cause life-threatening symptoms.
Less serious side effects may include:
mild eye irritation;
runny or stuffy nose, sore throat;
headache; or
unusual or unpleasant taste in your mouth.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
It is not likely that other drugs you take orally or inject will have an effect on bepotastine ophthalmic used in the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
See also: Bepreve side effects (in more detail)
Debridat AP may be available in the countries listed below.
Trimebutine maleate (a derivative of Trimebutine) is reported as an ingredient of Debridat AP in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0076675-97-3
C22-H32-O4
360
Anti-inflammatory agent
11beta,17α-Dihydroxy-17-propionylandrost-4-en-3-on (IUPAC)
11beta,17α-Dihydroxy-17-propionylandrost-4-en-3-one (WHO)
Androst-4-en-3-one,11beta-hydroxy-17α-(1-oxobutoxy)-
International Drug Name Search
Glossary
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| WHO | World Health Organization |
Amisulpride Arrow may be available in the countries listed below.
Amisulpride is reported as an ingredient of Amisulpride Arrow in the following countries:
International Drug Name Search
Vida Famodine may be available in the countries listed below.
Famotidine is reported as an ingredient of Vida Famodine in the following countries:
International Drug Name Search
Acantex may be available in the countries listed below.
Ceftriaxone is reported as an ingredient of Acantex in the following countries:
Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Acantex in the following countries:
International Drug Name Search
Aténolol Winthrop may be available in the countries listed below.
Atenolol is reported as an ingredient of Aténolol Winthrop in the following countries:
International Drug Name Search
Chlortetravet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Chlortetracycline hydrochloride (a derivative of Chlortetracycline) is reported as an ingredient of Chlortetravet in the following countries:
International Drug Name Search
Busmocalm may be available in the countries listed below.
Scopolamine butylbromide (a derivative of Scopolamine) is reported as an ingredient of Busmocalm in the following countries:
International Drug Name Search
In the US, Opticrom (cromolyn ophthalmic) is a member of the drug class ophthalmic antihistamines and decongestants and is used to treat Conjunctivitis - Allergic, Keratitis and Keratoconjunctivitis.
US matches:
UK matches:
Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Opticrom in the following countries:
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Opticrom in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Prednisone Merck may be available in the countries listed below.
Prednisone is reported as an ingredient of Prednisone Merck in the following countries:
International Drug Name Search
CetirHexal may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of CetirHexal in the following countries:
International Drug Name Search
Generic Name: diphtheria, haemophilus, pertussis, tetanus, and polio (dif THEER ee a, hem OFF il us, per TUS is, TET a nus, POE lee oh)
Brand Names: Pentacel
Diphtheria, haemophilus influenzae, pertussis, tetanus, and polio are serious diseases caused by bacteria.
Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, or death.
Haemophilus influenzae can cause minor flu symptoms or it can cause more serious symptoms such as swelling around the throat, making it hard to swallow or breathe. Haemophilus influenzae can also cause swelling of the membranes around the brain and spinal cord (meningitis).
Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.
Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.
Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.
Diphtheria, haemophilus influenzae, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.
The diphtheria, haemophilus influenzae, pertussis, tetanus, and polio vaccine is used to help prevent these diseases in children who are ages 6 weeks through 4 years (before the 5th birthday).
This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Like any vaccine, the diphtheria, haemophilus influenzae, pertussis, tetanus, and polio vaccine may not provide protection from disease in every person.
The diphtheria, haemophilus influenzae, pertussis, tetanus, and polio vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months, 6 months, and 15 to 18 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.
Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.
Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with diphtheria, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Your child may not be able to receive this vaccine if he or she has ever received a similar vaccine that caused any of the following within 48 hours:
a very high fever (over 104 degrees);
excessive crying for 3 hours or longer;
fainting or going into shock;
seizure (convulsions); or
Guillain-Barré syndrome (within 6 weeks after receiving a vaccine containing tetanus).
Before receiving this vaccine, tell the doctor if your child has:
a history of seizures;
a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
if the child is using steroid medication or receiving cancer chemotherapy or radiation treatment; or
a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments.
Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.
This vaccine is given as an injection into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.
The diphtheria, haemophilus influenzae, pertussis, tetanus, and polio vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months, 6 months, and 15 to 18 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.
Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.
Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.
Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.
An overdose of this vaccine is unlikely to occur.
Follow your doctor's instructions about any restrictions on food, beverages, or activity after receiving the vaccine.
Becoming infected with diphtheria, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Call your doctor at once if the child has any of these serious side effects:
extreme drowsiness, fainting;
fussiness, irritability, crying for an hour or longer;
seizure (black-out or convulsions); or
high fever.
Less serious side effects may include:
redness, pain, tenderness, or swelling where the shot was given;
low fever;
mild fussiness or crying;
headache or tiredness;
joint pain, body aches;
loss of appetite; or
mild nausea, diarrhea, or vomiting.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usual Pediatric Dose for Haemophilus influenzae Prophylaxis:
Diphtheria/haemophilus/pertussis/tetanus/polio (Pentacel) vaccine is approved for administration as a 4 dose series at 2, 4 and 6, and 15 18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel vaccine constitute a primary immunization course against pertussis. Three doses of Pentacel vaccine constitute a primary immunization course against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis
Children who have completed a four dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine at 4 to 6 years of age. Because the pertussis antigens in DAPTACEL vaccine are the same as those in Pentacel vaccine (although with different amounts of detoxified PT and FHA), these children should receive DAPTACEL vaccine as their fifth dose of DTaP. However, data are not available to evaluate the safety of DAPTACEL vaccine following four previous doses of Pentacel vaccine.
Children previously vaccinated with one or more doses of DAPTACEL vaccine: Pentacel vaccine may be used to complete the first 4 doses of the DTaP series in infants and children who have received 1 or more doses of DAPTACEL vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of IPV: Pentacel vaccine may be used to complete the 4 dose IPV series in infants and children who have received 1 or more doses of another licensed IPV vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of Haemophilus B conjugate vaccine: Pentacel vaccine may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of a Haemophilus B conjugate vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated. If different brands of Haemophilus B conjugate vaccines are administered to complete the series, three primary immunizing doses are needed, followed by a booster dose.
Usual Pediatric Dose for Poliomyelitis Prophylaxis:
Diphtheria/haemophilus/pertussis/tetanus/polio (Pentacel) vaccine is approved for administration as a 4 dose series at 2, 4 and 6, and 15 18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel vaccine constitute a primary immunization course against pertussis. Three doses of Pentacel vaccine constitute a primary immunization course against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis
Children who have completed a four dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine at 4 to 6 years of age. Because the pertussis antigens in DAPTACEL vaccine are the same as those in Pentacel vaccine (although with different amounts of detoxified PT and FHA), these children should receive DAPTACEL vaccine as their fifth dose of DTaP. However, data are not available to evaluate the safety of DAPTACEL vaccine following four previous doses of Pentacel vaccine.
Children previously vaccinated with one or more doses of DAPTACEL vaccine: Pentacel vaccine may be used to complete the first 4 doses of the DTaP series in infants and children who have received 1 or more doses of DAPTACEL vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of IPV: Pentacel vaccine may be used to complete the 4 dose IPV series in infants and children who have received 1 or more doses of another licensed IPV vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of Haemophilus B conjugate vaccine: Pentacel vaccine may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of a Haemophilus B conjugate vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated. If different brands of Haemophilus B conjugate vaccines are administered to complete the series, three primary immunizing doses are needed, followed by a booster dose.
Usual Pediatric Dose for Diphtheria Prophylaxis:
Diphtheria/haemophilus/pertussis/tetanus/polio (Pentacel) vaccine is approved for administration as a 4 dose series at 2, 4 and 6, and 15 18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel vaccine constitute a primary immunization course against pertussis. Three doses of Pentacel vaccine constitute a primary immunization course against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis
Children who have completed a four dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine at 4 to 6 years of age. Because the pertussis antigens in DAPTACEL vaccine are the same as those in Pentacel vaccine (although with different amounts of detoxified PT and FHA), these children should receive DAPTACEL vaccine as their fifth dose of DTaP. However, data are not available to evaluate the safety of DAPTACEL vaccine following four previous doses of Pentacel vaccine.
Children previously vaccinated with one or more doses of DAPTACEL vaccine: Pentacel vaccine may be used to complete the first 4 doses of the DTaP series in infants and children who have received 1 or more doses of DAPTACEL vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of IPV: Pentacel vaccine may be used to complete the 4 dose IPV series in infants and children who have received 1 or more doses of another licensed IPV vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of Haemophilus B conjugate vaccine: Pentacel vaccine may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of a Haemophilus B conjugate vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated. If different brands of Haemophilus B conjugate vaccines are administered to complete the series, three primary immunizing doses are needed, followed by a booster dose.
Usual Pediatric Dose for Pertussis Prophylaxis:
Diphtheria/haemophilus/pertussis/tetanus/polio (Pentacel) vaccine is approved for administration as a 4 dose series at 2, 4 and 6, and 15 18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel vaccine constitute a primary immunization course against pertussis. Three doses of Pentacel vaccine constitute a primary immunization course against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis
Children who have completed a four dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine at 4 to 6 years of age. Because the pertussis antigens in DAPTACEL vaccine are the same as those in Pentacel vaccine (although with different amounts of detoxified PT and FHA), these children should receive DAPTACEL vaccine as their fifth dose of DTaP. However, data are not available to evaluate the safety of DAPTACEL vaccine following four previous doses of Pentacel vaccine.
Children previously vaccinated with one or more doses of DAPTACEL vaccine: Pentacel vaccine may be used to complete the first 4 doses of the DTaP series in infants and children who have received 1 or more doses of DAPTACEL vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of IPV: Pentacel vaccine may be used to complete the 4 dose IPV series in infants and children who have received 1 or more doses of another licensed IPV vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of Haemophilus B conjugate vaccine: Pentacel vaccine may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of a Haemophilus B conjugate vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated. If different brands of Haemophilus B conjugate vaccines are administered to complete the series, three primary immunizing doses are needed, followed by a booster dose.
Usual Pediatric Dose for Tetanus Prophylaxis:
Diphtheria/haemophilus/pertussis/tetanus/polio (Pentacel) vaccine is approved for administration as a 4 dose series at 2, 4 and 6, and 15 18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel vaccine constitute a primary immunization course against pertussis. Three doses of Pentacel vaccine constitute a primary immunization course against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H influenzae type B invasive disease, and poliomyelitis
Children who have completed a four dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine at 4 to 6 years of age. Because the pertussis antigens in DAPTACEL vaccine are the same as those in Pentacel vaccine (although with different amounts of detoxified PT and FHA), these children should receive DAPTACEL vaccine as their fifth dose of DTaP. However, data are not available to evaluate the safety of DAPTACEL vaccine following four previous doses of Pentacel vaccine.
Children previously vaccinated with one or more doses of DAPTACEL vaccine: Pentacel vaccine may be used to complete the first 4 doses of the DTaP series in infants and children who have received 1 or more doses of DAPTACEL vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of IPV: Pentacel vaccine may be used to complete the 4 dose IPV series in infants and children who have received 1 or more doses of another licensed IPV vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated.
Children previously vaccinated with one or more doses of Haemophilus B conjugate vaccine: Pentacel vaccine may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of a Haemophilus B conjugate vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel vaccine. However, the safety and efficacy of Pentacel vaccine in such infants have not been evaluated. If different brands of Haemophilus B conjugate vaccines are administered to complete the series, three primary immunizing doses are needed, followed by a booster dose.
Also tell the doctor if your child has received drugs or treatments in the past 2 weeks that can weaken the immune system, including:
an oral, nasal, inhaled, or injectable steroid medicine;
medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).
If your child is using any of these drugs, this vaccine may not work as well.
This list is not complete and there may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.
Klorasüksinat may be available in the countries listed below.
Chloramphenicol succinate sodium (a derivative of Chloramphenicol) is reported as an ingredient of Klorasüksinat in the following countries:
International Drug Name Search
Gen-Baclofen may be available in the countries listed below.
Baclofen is reported as an ingredient of Gen-Baclofen in the following countries:
International Drug Name Search
Niflumic may be available in the countries listed below.
Niflumic Acid is reported as an ingredient of Niflumic in the following countries:
International Drug Name Search
Klenac may be available in the countries listed below.
Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Klenac in the following countries:
International Drug Name Search
Fiorance may be available in the countries listed below.
Ipriflavone is reported as an ingredient of Fiorance in the following countries:
International Drug Name Search
Reptor may be available in the countries listed below.
Ursodeoxycholic Acid is reported as an ingredient of Reptor in the following countries:
International Drug Name Search
Asiben may be available in the countries listed below.
Albendazole is reported as an ingredient of Asiben in the following countries:
International Drug Name Search
Ceftriaxone Novexal may be available in the countries listed below.
Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Ceftriaxone Novexal in the following countries:
International Drug Name Search
Bufexamac-ratiopharm may be available in the countries listed below.
Bufexamac is reported as an ingredient of Bufexamac-ratiopharm in the following countries:
International Drug Name Search
Racexon may be available in the countries listed below.
Ceftriaxone is reported as an ingredient of Racexon in the following countries:
International Drug Name Search
Gotabiotic Plus may be available in the countries listed below.
Dexamethasone is reported as an ingredient of Gotabiotic Plus in the following countries:
Tobramycin is reported as an ingredient of Gotabiotic Plus in the following countries:
International Drug Name Search
Ropark may be available in the countries listed below.
Ropinirole hydrochloride (a derivative of Ropinirole) is reported as an ingredient of Ropark in the following countries:
International Drug Name Search
Rx only
Prescribing Information
Diclofenac Sodium Extended-release Tablets are a benzeneacetic acid derivative. Diclofenac Sodium is available as extended-released tablets of 100 mg for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula:
The inactive ingredients in Diclofenac Sodium Extended-release Tablets include: anhydrous lactose, colloidal silicon dioxide, D & C Red # 27 (phloxine aluminum lake), hydroxyethyl cellulose, hypromellose, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide, and triacetin.
USP dissolution test is pending
Diclofenac Sodium Extended-release Tablets are a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of Diclofenac Sodium Extended-release Tablets, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.
Diclofenac is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1). When Diclofenac Sodium Extended-release Tablets are taken with food, there is a delay of 1 to 2 hours in the Tmax and a two-fold increase in Cmax values. The extent of absorption of Diclofenac, however, is not significantly affected by food intake.
| PK Parameter | Normal Healthy Adults (18 to 48 yrs.) | |
|---|---|---|
| Mean | Coefficient of Variation (%) | |
| Absolute Bioavailability (%) [N = 7] | 55 | 40 |
| Tmax (hr) [N = 12] | 5.3 | 28 |
| Oral Clearance (CL/F; mL/min) [N = 12] | 895 | 56 |
| Renal Clearance (% unchanged drug in urine) [N = 7] | <1 | – |
| Apparent Volume of Distribution (V/F; L/kg) [N = 56] | 1.4 | 58 |
| Terminal Half-life (hr) [N = 56] | 2.3 | 48 |
The apparent volume of distribution (V/F) of Diclofenac sodium is 1.4 L/kg. Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Serum protein binding is constant over the concentration range (0.15 to 105 µg/mL) achieved with recommended doses.
Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of Diclofenac.
Five Diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy-Diclofenac. The major Diclofenac metabolite, 4'-hydroxy-Diclofenac, has very weak pharmacologic activity. The formation of 4'-hydroxy Diclofenac is primarily mediated by CPY2C9. Both Diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CPY2C8 may also play a role in Diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy- and 3'-hydroxy-Diclofenac. In patients with renal dysfunction, peak concentrations of metabolites 4'-hydroxy- and 5-hydroxy-Diclofenac were approximately 50% and 4% of the parent compound after single oral dosing compared to 27% and 1% in normal healthy subjects.
Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Little or no free unchanged Diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged Diclofenac plus metabolites. Because renal elimination is not a significant pathway of elimination for unchanged Diclofenac, dosing adjustment in patients with mild to moderate renal dysfunction is not necessary. The terminal half-life of unchanged Diclofenac is approximately 2 hours.
When coadministered with voriconazole (inhibitor of CYP2C9, 2C19, and 3A4 enzyme), the Cmax and AUC of Diclofenac increased by 114% and 78%, respectively (see PRECAUTIONS, Drug Interactions).
Pediatric: The pharmacokinetics of Diclofenac Sodium Extended-release Tablets have not been investigated in pediatric patients.
Race: Pharmacokinetic differences due to race have not been identified.
Hepatic Insufficiency: Hepatic metabolism accounts for almost 100% of Diclofenac Sodium Extended-release Tablets elimination, so patients with hepatic disease may require reduced doses of Diclofenac Sodium Extended-release Tablets compared to patients with normal hepatic function.
Renal Insufficiency: Diclofenac pharmacokinetics has been investigated in subjects with renal insufficiency. No differences in the pharmacokinetics of Diclofenac have been detected in studies of patients with renal impairment. In patients with renal impairment (inulin clearance 60 to 90, 30 to 60, and <30 mL/min; N=6 in each group), AUC values and elimination rate were comparable to those in healthy subjects.
Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release Tablets and other treatment options before deciding to use Diclofenac Sodium Extended-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac Sodium Extended-release Tablets are indicated:
Diclofenac Sodium Extended-release Tablets are contraindicated in patients with known hypersensitivity to Diclofenac.
Diclofenac Sodium Extended-release Tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactic Reactions, and PRECAUTIONS, Preexisting Asthma).
Diclofenac Sodium Extended-release Tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS, GI Effects).
Two large, controlled, clinical trials of COX-2 selective NSAID for the treatment of pain in the first 10 to14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
NSAIDs can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Diclofenac Sodium Extended-release Tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Fluid retention and edema have been observed in some patients taking NSAIDs. Diclofenac Sodium Extended-release Tablets should be used with caution in patients with fluid retention or heart failure.
NSAIDs, including Diclofenac Sodium Extended-release Tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and, therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Caution should be used when initiating treatment with Diclofenac Sodium Extended-release Tablets in patients with considerable dehydration.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of nonsteroidal anti-inflammatory drug therapy is usually followed by recovery to the pretreatment state.
No information is available from controlled clinical studies regarding the use of Diclofenac Sodium Extended-release Tablets in patients with advanced renal disease. Therefore, treatment with Diclofenac Sodium Extended-release Tablets are not recommended in these patients with advanced renal disease. If Diclofenac Sodium Extended-release Tablets therapy must be initiated, close monitoring of the patient's renal function is advisable.
Elevations of one or more liver tests may occur during therapy with Diclofenac Sodium Extended-release Tablets. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continued therapy. Borderline elevations (i.e., less than 3 times the ULN [ULN=the Upper Limit of the Normal range]), or greater elevations of transaminases occurred in about 15% of Diclofenac-treated patients. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury.
In clinical trials, meaningful elevations (i.e., more than 3 times the ULN) of AST (GOT) (ALT was not measured in all studies) occurred in about 2% of approximately 5,700 patients at some time during Diclofenac treatment. In a large, open-label, controlled trial, of 3,700 patients treated for 2 to 6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of patients and included marked elevations (i.e., more than 8 times the ULN) in about 1% of the 3,700 patients. In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3 to 8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving Diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.
Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with Diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations.
In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with Diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
Physicians should measure transaminases periodically in patients receiving long-term therapy with Diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical data, and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with Diclofenac. However, severe hepatic reactions can occur at any time during treatment with Diclofenac.
If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), Diclofenac Sodium Extended-release Tablets should be discontinued immediately.
To minimize the possibility that hepatic injury will become severe between transaminase measurements, physicians should inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms), and the appropriate action patients should take if these signs and symptoms appear.
To minimize the potential risk for an adverse liver-related event in patients treated with Diclofenac Sodium Extended-release Tablets, the lowest effective dose should be used for the shortest duration possible. Caution should be exercised in prescribing Diclofenac Sodium Extended-release Tablets with concomitant drugs that are known to be potentially hepatotoxic (e.g., antibiotics, anti-epileptics).
As with other NSAIDs, anaphylactic reactions may occur in patients with the aspirin triad and in patients without known sensitivity to NSAIDs or known prior exposure to Diclofenac Sodium Extended-release Tablets. Diclofenac Sodium Extended-release Tablets should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma). Anaphylaxis-type reactions have been reported with NSAID products, including with Diclofenac products, such as Diclofenac Sodium Extended-release Tablets. Emergency help should be sought in cases where an anaphylactoid reaction occurs.
NSAIDs, including Diclofenac Sodium Extended-release Tablets, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
In late pregnancy, as with other NSAIDs, Diclofenac Sodium Extended-release Tablets should be avoided because it may cause premature closure of the ductus arteriosus.
Diclofenac Sodium Extended-release Tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Diclofenac Sodium Extended-release Tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Anemia is sometimes seen in patients receiving NSAIDs, including Diclofenac Sodium Extended-release Tablets. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Diclofenac Sodium Extended-release Tablets, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving Diclofenac Sodium Extended-release Tablets who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross-reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Diclofenac Sodium Extended-release Tablets should not be administered to patients with this form of aspirin sensitivity and should be used with caution in all patients with preexisting asthma.
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. In patients on long-term treatment with NSAIDs, including Diclofenac Sodium Extended-release Tablets, the CBC and a chemistry profile (including transaminase levels) should be checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, Diclofenac Sodium Extended-release Tablets should be discontinued.
Aspirin: When Diclofenac Sodium Extended-release Tablets are administered with aspirin, its protein binding is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.
Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Cyclosporine: Diclofenac Sodium Extended-release Tablets, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with Diclofenac Sodium Extended-release Tablets may increase cyclosporine's nephrotoxicity. Caution should be used when Diclofenac Sodium Extended-release Tablets are administered concomitantly with cyclosporine.
ACE-inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
Furosemide: Clinical studies, as well as postmarketing observations, have shown that Diclofenac Sodium Extended-release Tablets can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition or renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as to assure diuretic efficacy.
Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
CYP2C9 Inhibitors or Inducers: Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Coadministration of Diclofenac with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of Diclofenac whereas coadministration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of Diclofenac. Use caution when dosing Diclofenac with CYP2C9 inhibitors or inducers, a dosage adjustment may be warranted (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Drug Interactions).
Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women.
Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.
In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Diclofenac Sodium Extended-release Tablets on labor and delivery in pregnant women are unknown.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Diclofenac Sodium Extended-release Tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).
In patients taking Diclofenac Sodium Extended-release Tablets or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 10% of patients are:
Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.
Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.
Additional adverse experiences reported occasionally include:
Body as a Whole: fever, infection, sepsis
Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope
Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice
Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia
Metabolic and Nutritional: weight changes
Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo
Respiratory System: asthma, dyspnea
Skin and Appendages: alopecia, photosensitivity, sweating increased
Special Senses: blurred vision
Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure
Other adverse reactions, which occur rarely are:
Body as a Whole: anaphylactic reactions, appetite changes, death
Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis
Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis
Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Metabolic and Nutritional: hyperglycemia
Nervous System: convulsions, coma, hallucinations, meningitis
Respiratory System: respiratory depression, pneumonia
Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
Special Senses: conjunctivitis, hearing impairment
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release Tablets and other treatment options before deciding to use Diclofenac Sodium Extended-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Diclofenac Sodium Extended-release Tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of osteoarthritis, the recommended dosage is 100 mg q.d.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg q.d. In the rare patient where Diclofenac Sodium Extended-release Tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg b.i.d. if the benefits outweigh the clinical risks of increased side effects.
Different formulations of Diclofenac [Diclofenac sodium enteric-coated tablets; Diclofenac sodium extended-release tablets; Diclofenac potassium immediate-release tablets] are not necessarily bioequivalent even if the milligram strength is the same.
Diclofenac Sodium Extended-release Tablets
100 mg - unscored, pink, round film coated tablets, engraved with "93" on one side and "1041" on the other side.
Bottles of 100 NDC 0093-1041-01
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) (see USP Controlled Room Temperature).
Protect from moisture.
Dispense in tight container (USP).
| Diclofenac (dye-KLOE-fen-ak) |
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:
NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
The chance of a person getting an ulcer or bleeding increases with:
NSAID medicines should only be used:
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
Tell your healthcare provider:
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Serious side effects include:
Other side effects include:
Get emergency help right away if you have any of the following symptoms:
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
NSAID medicines that need a prescription
| Generic Name | Tradename |
|---|---|
| |
| Celecoxib | Celebrex |
| Diclofenac | Cataflam, Voltaren, Arthrotec (combined with misoprostol) |
| Diflunisal | Dolobid |
| Etodolac | Lodine, Lodine XL |
| Fenoprofen | Nalfon, Nalfon 200 |
| Flurbiprofen | Ansaid |
| Ibuprofen | Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone) |
| Indomethacin | Indocin, Indocin SR, Indo-Lemmon, Indomethagan |
| Ketoprofen | Oruvail |
| Ketorolac | Toradol |
| Mefenamic Acid | Ponstel |
| Meloxicam | Mobic |
| Nabumetone | Relafen |
| Naproxen | Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole) |
| Oxaprozin | Daypro |
| Piroxicam | Feldene |
| Sulindac | Clinoril |
| Tolmetin | Tolectin, Tolectin DS, Tolectin 600 |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised June 2011
Manufactured for:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Manufactured In Canada By:
Valeant Pharmaceuticals International, Inc.
Steinbach, MB R5G1Z7
Canada
LB0007-04
Rev. 06/2011
NDC 0093-1041-01
Diclofenac
SODIUM
Extended-release
Tablets
100 mg
Once-A-Day Dosage
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
Rx only
100 TABLETS
TEVA
| Diclofenac SODIUM Diclofenac sodium tablet, film coated, extended release | |||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||
