Cambia

Generic name: diclofenac
Drug class: Nonsteroidal anti-inflammatory drugs

What is Cambia?

Cambia is a prescription medicine used to treat migraine attacks in adults. It does not prevent or lessen the number of migraines you have, and it is not for other types of headaches. Cambia contains diclofenac potassium (a non-steroidal anti-inflammatory drug or NSAID).

Description

      CAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA is available as a buffered soluble powder, designed to be mixed with water prior to oral administration. CAMBIA is a white to off-white, buffered, flavored powder for oral solution packaged in individual unit dose packets [see How Supplied/Storage and Handling (16)].

      The chemical name for diclofenac potassium is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight of diclofenac potassium is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structural formula:

The inactive ingredients in CAMBIA include: aspartame (equivalent to 25 mg phenylalanine), flavoring agents (anise and mint), glycerol behenate, mannitol, potassium bicarbonate, and saccharin sodium.

 Mechanism of Action

      CAMBIA is a non-steroidal anti-inflammatory drug (NSAID). The mechanism of action of CAMBIA, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

What is the most important information I should know about Cambia?

Cambia contains diclofenac (a non-steroidal anti-inflammatory drug or NSAID).

NSAIDs, including Cambia, can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
  • with increasing doses of NSAIDs
  • with longer use of NSAIDs

Do not take NSAIDs, including Cambia, right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs, including Cambia, after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
  • anytime during use
  • without warning symptoms
  • that may cause death

• The risk of getting an ulcer or bleeding increases with:
  • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
  • increasing doses of NSAIDs
  • older age
  • longer use of NSAIDs
  • poor health
  • smoking
  • advanced liver disease
  • drinking alcohol
  • bleeding problems

• Cambia should only be used:
  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

Who should not take Cambia?

Do not take Cambia:

• if you have had an asthma attack, hives, or other allergic reaction with aspirin, diclofenac, or any other NSAIDs.
• right before or after heart bypass surgery.

What should I tell my healthcare provider before taking Cambia?

Before taking Cambia, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems
• have a history of stomach ulcer or bleeding in your stomach or intestines
• have any allergies to any medicines
• have chest pain, shortness of breath, irregular heartbeats
• have high blood pressure
• have asthma
• are pregnant, think you might be pregnant, or are trying to become pregnant. Cambia should not be used by pregnant women, especially after 29 weeks of pregnancy unless directed by your healthcare provider to do so. Cambia may cause problems in your unborn child or complications during your delivery
• are breastfeeding or plan to breastfeed. It is not known if Cambia passes into your breast milk. You and your doctor should decide if you will take Cambia or breastfeed. You should not do both
• have a headache that is different from your usual migraine

Tell your healthcare provider about all of the medicines you take, including prescription or over-the- counter medicines, vitamins or herbal supplements. NSAIDs, like Cambia, and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

Especially tell your doctor if you take:

• aspirin
• any anticoagulant medicines (warfarin, Coumadin, Jantoven)

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take Cambia?

Take Cambia exactly as your healthcare provider tells you to take it.

Take 1 dose of Cambia to treat your migraine headache:

• remove one single dose packet from a set of three packets
• open packet only when you are ready to use it
• empty contents of packet into 1 to 2 ounces or 2 to 4 tablespoons (30 to 60 mL) of water
• mix well and drink the water and powder mixture
• throw away empty packet in a safe place and out of the reach of children.
• taking Cambia with food may cause a reduction in effectiveness compared to taking Cambia on an empty stomach
• do not take more Cambia than directed by your healthcare provider. In case of overdose, get medical help or contact a Poison Control Center right away

What are the possible side effects of Cambia?

Cambia can cause serious side effects, including:

• See “What is the most important information I should know about Cambia?”
• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• bleeding and ulcers in the stomach and intestine
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• asthma attacks in people who have asthma
• medication overuse headaches. Some people who use too much Cambia may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Cambia.

Other side effects of NSAIDs include:

• stomach pain
• constipation
• diarrhea
• gas
• heartburn
• nausea
• vomiting
• dizziness

Get emergency help right away if you get any of the following symptoms:

• shortness of breath or trouble breathing
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat

Stop taking Cambia and call your healthcare provider right away if you get any of the following symptoms:

• nausea that seems out of proportion to your migraine
• sudden or severe pain in your belly
• more tired or weaker than usual
• diarrhea
• itching
• your skin or eyes look yellow
• indigestion or stomach pain
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• more tired or weaker than usual
• skin rash or blisters with fever
• swelling of the arms, legs, hands and feet
• flu-like symptoms

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

• Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some NSAIDs are sold in lower doses without a prescription (over-the counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

How do I store Cambia?

Store at 25°C (77°F). Excursions permitted from 15°C-30°C (59°F-86°F).

What are the ingredients in Cambia?

Active ingredients: diclofenac potassium

Inactive ingredients: glyceryl dibehenate, mannitol, potassium bicarbonate, sucralose

Label

PRINCIPAL DISPLAY PANEL