Zimulti

Generic name: rimonabant
Company: Sanofi-Aventis

What is Zimulti?

• Zimulti (rimonabant) was the first in a new class of therapeutic agents called Cannabinoid-1 Receptor Blockers (CB1).
• Zimulti was studied in the treatment of obesity, as an aid for smoking cessation, and related conditions.

How does Zimulti work?

• Zimulti acts by selectively blocking CB1 receptors found in the brain and in peripheral organs important in glucose and lipid (or fat) metabolism, including adipose tissue, the liver, gastrointestinal tract and muscle.²
• CB1 receptor blockade with Zimulti acts to decrease the overactivity of the endocannabinoid system (EC system).^3,4 The EC system is a recently characterised physiological system that includes receptors such as the CB1 receptor and it has been shown to play an important role in regulating body weight and in controlling energy balance, as well as glucose and lipid (or fat) metabolism.
• Zimulti switches off the same brain circuits that make people hungry when they smoke cannabis. As a result, people who take Zimulti eat less and lose weight.

What is Zimulti used for?

• Zimulti was studied to be used complementary to diet and exercise to treat obese or overweight patients who suffer from Type 2 diabetes and abnormal levels of fat in the blood.
• Sanofi argued that Zimulti could also prevent the risk of cardiovascular disease.

Does Zimulti also aid smoking cessation?

• Zimulti had been studied by Sanofi-Aventis as an aid to smoking cessation based on studies for up to one year in over 6,500 smokers motivated to quit smoking.
• Sanofi-Aventis submitted a New Drug Application for Zimulti to the FDA, who in turn issued a non-approvable letter for Zimulti use in smoking cessation, and an approvable letter for use in weight management. However, in June of 2007, the FDA''s Endocrine and Metabolic Drugs Advisory Committee recommended against the approval of rimonabant for any indication due to concerns over dangerous psychological side effects, including suicidality and depression. Subsequently, the FDA did not approve rimonabant, and it has never been marketed in the United States.

What were the results of the clinical studies?

• In clinical studies, Zimulti was shown to improve a wide array of cardiometabolic risk factors as well as promote sustained weight loss.^5,6
• Approximately half of the observed improvement in HDL-cholesterol, triglycerides and HbA1C (an indicator of blood sugar control) in patients who received Zimulti 20mg was beyond that expected from weight loss alone.⁷

Zimulti side effects

• Side effects in the trial on Zimulti in obesity were vomiting and nausea, forcing about 19 percent of patients to leave the trial versus 13 percent of those who took placebo.
• Clinical studies found that 26 percent of people taking Zimulti reported psychiatric symptoms, including anxiety, insomnia, panic attacks as well as increases in aggression and agitation compared to patients given a placebo.
• Zimulti has also been shown to cause increased suicidal tendencies and other depressive symptoms.⁸

References:

1. Personal Communication. Sanofi-Aventis Medical Information Department. Rimonabant availability. September 12, 2011
2. Pagotto U. Pasquali R. Fighting obesity and associated risk factors by antagonising cannabinoid type 1 receptors. Lancet. 2005; 365: 1363-64.
3. Van Gaal LF, Rissanen, AM, Scheen AJ, Ziegler O, Rössner S for the RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005; 365: 1389-97.
4. Marzo V, et al. Leptin-regulated endocannabinoids are involved in maintaining food intake. Nature. 2001;410:822-825.
5. Després, J.P. et al. Effect of Rimonabant on Body Weight and the Metabolic Syndrome in Overweight Patients. New England Journal of Medicine, November, 16, 2005.
6. Van Gaal L, et al. Effects Of The Cannabinoid-1 Receptor Blocker Rimonabant On Weight Reduction And Cardiovascular Risk Factors In Overweight Patients: 1-Year Experience From The RIO-Europe Study. The Lancet. 365;1389-1397.
7. Zimulti Summary of Product Characteristics
8. Testimony Before FDA Advisory Committee Meeting on Rimonabant (HRG Publication #1815), Testimony of Sidney Wolfe, M.D., Ben Wolpaw and Elizabeth Barbehenn Ph.D. Health Research Group of Public Citizen. FDA Endocrine Metabolic Drugs Advisory Committee Meeting on Rimonabant: June 13, 2007

Sources:

Rimonabant Accepted for Filing By the FDA June 23, 2005

Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation February 17, 2006

FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risk Factors June 13, 2007

Weight Loss Drug Zimulti (rimonabant) Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA June 13, 2007

Sanofi-Aventis to Discontinue Rimonabant Trials for All Indications November 6, 2008

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Zinacef

Generic name: cefuroxime (injection route, intravenous route) [ sef-ue-ROX-eem ]
Drug class: Second generation cephalosporins

Medically reviewed by Drugs.com. Last updated on Jan 29, 2023.

Commonly used brand name(s)

In the U.S.

• Zinacef

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: 2nd Generation Cephalosporin

Uses for Zinacef

Cefuroxime is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth.

This medicine is available only with your doctor''s prescription.

Before using Zinacef

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and, in effective doses, has not shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in the elderly and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live
• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Levonorgestrel
• Mestranol
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis, history of or
• Gastrointestinal disease, history of— cefuroxime may make these worse

• Kidney disease or
• Liver disease or
• Poor nutritional status—these may be worsened by cefuroxime and you may need to have vitamin K

• Kidney problems, temporary or permanent— these may effect how much cefuroxime is in your body, reducing your dose might be needed.

Proper use of Zinacef

Dosing

The dose of this medicine will be different for different patients. Follow your doctor''s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form
  • • Adults and teenagers—750 mg to 3 grams every six to eight hours usually for 5 to 14 days, injected into a muscle or vein. Gonorrhea is treated with a single dose of 1.5 grams, injected into a muscle; the total 1.5-gram dose is divided into two doses and injected into muscles at two separate places on the body, and given along with a single, oral 1-gram dose of probenecid.
    • Infants and children 1 month of age and older—12.5 to 150 mg per kg (5.68 to 68 mg per pound) of body weight every six to eight hours, injected into a muscle or vein.
    • Newborns—30 to 100 mg per kg (13.6 to 45.5 mg per pound) of body weight every eight to twelve hours, injected into a vein.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Consult your health care professional about how to store this medicine.

Precautions while using Zinacef

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Zinacef side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools
• chest pain
• chills
• cough
• fever
• painful or difficult urination
• shortness of breath
• sore throat
• sores, ulcers, or white spots on lips or in mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Abdominal or stomach cramps
• abdominal or stomach tenderness or pain
• bloating
• bluish color or changes in skin color
• diarrhea, watery and severe, which may also be bloody
• difficulty in breathing or swallowing, wheezing, shortness of breath
• fast heartbeat
• fever
• hives or welts
• increased thirst
• muscle spasm or jerking of all extremities
• nausea or vomiting
• pain
• skin itching, rash, or redness
• sudden loss of consciousness
• swelling of face, throat, or tongue
• swelling of foot or leg
• tenderness
• unusual weight loss

Rare

• Blistering, peeling, loosening of skin
• bloody or cloudy urine
• dizziness
• fast heartbeat
• greatly decreased frequency of urination or amount of urine
• hearing loss, mild to moderate
• joint or muscle pain
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• red or irritated eyes
• redness, tenderness, itching, burning, or peeling of skin
• red skin lesions, often with a purple center
• sore throat
• tightness in chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Gas
• loss of appetite

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer