Accretropin

DRUG DESCRIPTION

Accretropin™ (recombinant human growth hormone (r-hGH); somatropin) is a protein
produced by recombinant DNA technology. It is produced during fermentation in
E. coli yielding a protein containing 192 amino acids. The N-terminal
amino acid, methionine, is later removed to yield a protein that is chemically
and physicochemically identical to pituitary derived human growth hormone, consisting
of 191 amino acids in a single polypeptide chain.

Accretropin™ (somatropin injection) is distributed in a liquid solution containing 1 mL of a 5 mg/mL
solution of growth hormone (15 IU/mL). The formulation also contains 0.75% NaCl,
0.34% Phenol (as preservative), 0.2% Pluronic F-68 (a non-ionic surfactant)
and is designed for subcutaneous administration. Accretropin™ (somatropin injection) is stabilized
to pH 6.0 with 10 mM NaPO₄ buffer.

Lumigan

DRUG DESCRIPTION

LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentylj-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C₂₅H₃₇NO₄. Its chemical structure is:

Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. LUMIGAN® (bimatoprost ophthalmic solution 0.03% for glaucoma) 0.01% and 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg.

LUMIGAN® 0.01% contains Active: bimatoprost 0.1 mg/mL; Preservative: benzalkonium chloride 0.2 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8-7.8.

LUMIGAN® 0.03% contains Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8-7.8.

What are the possible side effects of bimatoprost ophthalmic (Lumigan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using bimatoprost ophthalmic and call your doctor at once if you have any of these serious side effects:

• redness, swelling, itching, or pain in or around your eye;


• oozing or discharge from your eye;


• increased sensitivity to light;


• vision changes.

Less serious side effects may include:

...

Read All Potential Side Effects and See Pictures of Lumigan »

What are the precautions when taking bimatoprost ophthalmic solution 0.03% for glaucoma (Lumigan)?

Before using bimatoprost, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., latanoprost, travoprost); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., macular edema, iritis, uveitis, lens extraction/aphakia).

If you develop an eye infection or injury, or have eye surgery, check with your doctor about the continued use of your current bottle of bimatoprost. You may be advised to start using a new bottle.

This drug may cause temporary...

Read All Potential Precautions of Lumigan »

Lumigan Consumer (continued)

SIDE EFFECTS: Burning/stinging/irritation/redness of the eye, feeling as if something is in your eye, dry eyes, watering eyes, and increased sensitivity to light may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may slowly (over months to years) cause brown discoloration of the colored portion of the eye (iris). If you are using bimatoprost in only one eye, only that iris may change color. An increase in eyelash number/length/thickness and darkening of the eyelashes/eyelids may also occur in the treated eye. These changes may be permanent, but the long-term effects are uncertain. Notify your doctor if this occurs, and schedule regular eye exams to monitor it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, eye pain/swelling, swelling/redness of the eyelids.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using bimatoprost, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., latanoprost, travoprost); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., macular edema, iritis, uveitis, lens extraction/aphakia).

If you develop an eye infection or injury, or have eye surgery, check with your doctor about the continued use of your current bottle of bimatoprost. You may be advised to start using a new bottle.

This drug may cause temporary unstable vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Lumigan Patient Information Including Side Effects

Brand Names: Lumigan

Generic Name: bimatoprost ophthalmic (Pronunciation: bih MAT o prost)

• What is bimatoprost ophthalmic (Lumigan)?


• What are the possible side effects of bimatoprost ophthalmic (Lumigan)?


• What is the most important information I should know about bimatoprost ophthalmic (Lumigan)?


• What should I discuss with my health care provider before using bimatoprost ophthalmic (Lumigan)?


• How should I use bimatoprost ophthalmic (Lumigan)?


• What happens if I miss a dose (Lumigan)?


• What happens if I overdose (Lumigan)?


• What should I avoid while using bimatoprost ophthalmic (Lumigan)?


• What other drugs will affect bimatoprost ophthalmic (Lumigan)?


• Where can I get more information?

What is bimatoprost ophthalmic (Lumigan)?

Bimatoprost ophthalmic reduces pressure in the eye by increasing the amount of fluid that drains from the eye.

Bimatoprost ophthalmic is used to treat certain types of glaucoma and other causes of high pressure inside the eye. Bimatoprost is also used to improve fullness, length, and color of the eyelashes in people with a condition called hypotrichosis (HYE-poe-trye-KOE-sis), a lack of eyelash growth.

Bimatoprost ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of bimatoprost ophthalmic (Lumigan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using bimatoprost ophthalmic and call your doctor at once if you have any of these serious side effects:

• redness, swelling, itching, or pain in or around your eye;


• oozing or discharge from your eye;


• increased sensitivity to light;


• vision changes.

Less serious side effects may include:

• mild eye discomfort;


• dizziness;


• feeling like something is in your eye;


• dry or watery eyes; or


• stinging or burning of the eyes after using the drops.

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.

What is the most important information I should know about bimatoprost ophthalmic (Lumigan)?

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using bimatoprost before putting your contact lenses in.

Bimatoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

Do not allow the dropper 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.

After using this medication, wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

Related Drug Centers

• Lumigan

Sonata

DRUG DESCRIPTION

Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class.
The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide.
Its empirical formula is C₁₇H₁₅N₅O, and its
molecular weight is 305.34. The structural formula is shown below.

Zaleplon is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7.

Sonata® capsules contain zaleplon as the active ingredient. Inactive ingredients consist of microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1, FD&C green #3, and FD&C yellow #5.

What are the possible side effects of zaleplon (Sonata)?

Zaleplon may cause a severe allergic reaction. Stop taking zaleplon and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using zaleplon and call your doctor at once if you have any of these serious side effects:

• aggression, agitation, changes in behavior;


• thoughts of hurting yourself; or


• hallucinations (hearing or seeing things).

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Sonata »

What are the precautions when taking zaleplon (Sonata)?

Before taking zaleplon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, very high/low blood pressure, breathing problems (e.g., asthma), depression, history of drug/alcohol abuse.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting...

Read All Potential Precautions of Sonata »

Sonata Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, short-term memory loss, or lack of coordination may occur, especially during the first 2 hours after you take the medication. Taking the medication properly just before falling asleep will reduce your risk of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., agitation, seeing/hearing things that are not there, rare thoughts of suicide), unusual behavior.

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zaleplon.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking zaleplon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, very high/low blood pressure, breathing problems (e.g., asthma), depression, history of drug/alcohol abuse.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of this drug, especially memory problems.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Sonata Patient Information Including Side Effects

Brand Names: Sonata

Generic Name: zaleplon (Pronunciation: ZAH le plon)

• What is zaleplon (Sonata)?


• What are the possible side effects of zaleplon (Sonata)?


• What is the most important information I should know about zaleplon (Sonata)?


• What should I discuss with my healthcare provider before taking zaleplon (Sonata)?


• How should I take zaleplon (Sonata)?


• What happens if I miss a dose (Sonata)?


• What happens if I overdose (Sonata)?


• What should I avoid while taking zaleplon (Sonata)?


• What other drugs will affect zaleplon (Sonata)?


• Where can I get more information?

What is zaleplon (Sonata)?

Zaleplon is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Zaleplon is used to treat insomnia. This medication causes relaxation to help you fall asleep and stay asleep.

Zaleplon may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of zaleplon (Sonata)?

Zaleplon may cause a severe allergic reaction. Stop taking zaleplon and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using zaleplon and call your doctor at once if you have any of these serious side effects:

• aggression, agitation, changes in behavior;


• thoughts of hurting yourself; or


• hallucinations (hearing or seeing things).

Less serious side effects may include:

• day-time drowsiness, dizziness, "hangover" feeling;


• problems with memory or concentration;


• numbness or tingling;


• anxiety, depression, nervous feeling;


• problems with vision;


• headache;


• nausea, stomach pain, loss of appetite, constipation;


• dry mouth;


• increased menstrual pain (cramps);


• back pain, joint or muscle pain; or


• mild skin rash.

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.

What is the most important information I should know about zaleplon (Sonata)?

Zaleplon may cause a severe allergic reaction. Stop taking zaleplon and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Zaleplon will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 4 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zaleplon and talk with your doctor about another treatment for your sleep disorder.

Zaleplon can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not drink alcohol while you are taking zaleplon. It can increase some of the side effects of zaleplon, including drowsiness.

Zaleplon may be habit-forming and should be used only by the person it was prescribed for. Zaleplon should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms if you stop taking zaleplon after taking it over several days in a row. Do not stop taking zaleplon suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Related Drug Centers

• Sonata

Zotrim

DRUG DESCRIPTION

This product consists of trimethoprim/sulfamethoxazole double strength (160 mg/800 mg) tablets and phenazopyridine hydrochloride 200 mg tablets for oral administration.

Trimethoprim/sulfamethoxazole double strength tablets. Trimethoprim/sulfamethoxazole double strength is a synthetic antibacterial combination product. Each trimethoprim/sulfamethoxazole double strength tablet contains 160 mg trimethoprim and 800 mg sulfamethoxazole.

Trimethoprim is 2,4-pyrimidinediamine, 5-[(3,4,5-trimethoxyphenyl)methyl]. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32, the molecular formula C₁₄H₁₈N₄O₃. Its structual formula is:

Sulfamethoxazole is benzenesulfonamide, 4-amino-N-(5-methyl-3-isoxazolyl). It is an almost white, odorless, tasteless compound with a molecular weight of 253.28, the molecular formula C₁₀H₁₁N₃O₃S^. Its structual formula is:

Inactive Ingredients: Each trimethoprim/sulfamethoxazole double strength tablet contains magnesium stearate, pregelatinized starch and sodium starch glycolate.

Phenazopyridine Hydrochloride tablets. Each round maroon tablet contains 200 mg phenazopyridine hydrochloride, USP for oral administration. Phenazopyridine Hydrochloride is chemically designated 2,6-pyridinediamine, 3-(phenylazo) monohydrochloride with a molecular weigth of 249.70, the molecular formula C₁₁H₁₁N₅·HCl. Its structual formula is:

Inactive Ingredients: Each phenazopyridine hydrochloride tablet contains acacia, carnauba wax, confectioners sugar, corn starch powder, edible white ink, gelatin, hydrogenated vegetable oil, lactose, magnesium stearate, Opalux AS-3942 dark maroon, sodium starch glycolate, sucrose, talc powder and white bees wax.

Marinol

DRUG DESCRIPTION

Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-
trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas:

Dronabinol, the active ingredient in MARINOL® (dronabinol) Capsules, is
synthetic delta-9- tetrahydrocannabinol (delta-9-THC). Delta-9-tetrahydrocannabinol
is also a naturally occurring component of Cannabis sativa L. (Marijuana).

Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.

Capsules for oral administration: MARINOL (dronabinol) Capsules is supplied as round, soft gelatin capsules containing either 2.5 mg, 5 mg, or 10 mg dronabinol. Each MARINOL (dronabinol) Capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.

What are the possible side effects of dronabinol (Marinol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dronabinol and call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);


• paranoia, extreme fear;


• fast heart rate;


• feeling light-headed, fainting; or


• unusual thoughts or behavior.

Continue using dronabinol and talk with your doctor if you have any of these less...

Read All Potential Side Effects and See Pictures of Marinol »

What are the precautions when taking dronabinol (Marinol)?

Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular use/abuse of drugs/alcohol/other substances, heart disease, high blood pressure, mental/mood conditions (e.g., mania, depression, schizophrenia), seizure disorder.

This drug may make you dizzy or drowsy or affect your judgment. Do not engage in activities requiring alertness and clear thinking, such as driving or using machinery, until you know how this medication affects...

Read All Potential Precautions of Marinol »

Marinol Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, confusion, feeling "high", an exaggerated sense of well-being, lightheadedness, headache, red eyes, dry mouth, nausea, vomiting, stomach pain, clumsiness, or unsteadiness may occur, especially during the first several days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: weakness, flushing of the face, fast/pounding heartbeat, mental/mood changes (e.g., difficulty concentrating, memory loss, hallucinations, abnormal thoughts, paranoia, depression, nervousness), slurred speech, ringing in the ears, vision changes, fainting.

It is important that you take this medication under the supervision of a responsible adult because mental, mood, or behavior changes may occur. If you experience any such effects, remain calm and try not to panic. Tell your doctor immediately. Do not take any more dronabinol until after you consult with your doctor.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular use/abuse of drugs/alcohol/other substances, heart disease, high blood pressure, mental/mood conditions (e.g., mania, depression, schizophrenia), seizure disorder.

This drug may make you dizzy or drowsy or affect your judgment. Do not engage in activities requiring alertness and clear thinking, such as driving or using machinery, until you know how this medication affects you and until you are sure you can perform such activities safely. Alcohol can worsen these side effects. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially drowsiness and mental/mood changes.

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially drowsiness and mental/mood changes.

This medication is not recommended for use during pregnancy because of possible unborn baby/infant harm reported with marijuana exposure (dronabinol contains the active substance found in marijuana). Consult your doctor for more details.

This drug passes into breast milk. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Marinol Patient Information Including Side Effects

Brand Names: Marinol

Generic Name: dronabinol (Pronunciation: droe NAH bih nol)

• What is dronabinol (Marinol)?


• What are the possible side effects of dronabinol (Marinol)?


• What is the most important information I should know about dronabinol (Marinol)?


• What should I discuss with my health care provider before taking dronabinol (Marinol)?


• How should I take dronabinol (Marinol)?


• What happens if I miss a dose (Marinol)?


• What happens if I overdose (Marinol)?


• What should I avoid while taking dronabinol (Marinol)?


• What other drugs will affect dronabinol (Marinol)?


• Where can I get more information?

What is dronabinol (Marinol)?

Dronabinol is a man-made form of cannabis (marijuana is an herbal form of cannabis). Dronabinol causes many effects on your central nervous system.

Dronabinol is used to treat loss of appetite in people with AIDS. It is also used to treat severe nausea and vomiting that is caused by cancer chemotherapy. Dronabinol is for use only when other medications have been unable to control the nausea and vomiting.

Dronabinol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of dronabinol (Marinol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dronabinol and call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);


• paranoia, extreme fear;


• fast heart rate;


• feeling light-headed, fainting; or


• unusual thoughts or behavior.

Continue using dronabinol and talk with your doctor if you have any of these less serious side effects:

• mood changes;


• dizziness, trouble concentrating;


• feeling "high";


• weakness, lack of coordination;


• anxiety, confusion;


• stomach pain, nausea, vomiting, diarrhea;


• warmth or tingly feeling; or


• sleep problems (insomnia).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dronabinol (Marinol)?

Dronabinol may be habit-forming and should be used only by the person it was prescribed for. Dronabinol should never be given to another person, especially someone who has a history of drug addiction or habitual marijuana use. Keep the medication in a secure place where others cannot get to it.

Do not use dronabinol if you have ever had an allergic reaction to natural or man-made marijuana.

Before taking dronabinol, tell your doctor if you have a seizure disorder, high blood pressure, heart disease, a history of mental illness or drug addiction, or if you are also using other medicines that can affect your central nervous system, such as a tranquilizer, sleep medicine, or anti-psychotic medications.

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

Avoid using other medicines that affect the central nervous system (such as stimulants, diet pills, cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression, anxiety, mental illness, or Parkinson's disease). These other drugs can add to the effects of dronabinol.

Dronabinol causes effects that will impair your thinking or reactions. Do not drive or do anything that requires you to be awake and alert until the effects of dronabinol wear off.

There are many other medicines that can add to the side effects of dronabinol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Related Drug Centers

• Marinol

Zinacef

DRUG DESCRIPTION

Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for
parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate,
and it has the following chemical structure:

The empirical formula is C₁₆H₁₅N₄O₈S,
representing a molecular weight of 446.4.

ZINACEF (cefuroxime) contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity.

ZINACEF (cefuroxime) in sterile crystalline form is supplied in vials equivalent to 750 mg, 1.5 g, or 7.5 g of cefuroxime as cefuroxime sodium and in ADD-Vantage® vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of ZINACEF (cefuroxime) range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5.

ZINACEF (cefuroxime) is available as a frozen, iso-osmotic, sterile, nonpyrogenic solution with 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Approximately 1.4 g of Dextrose Hydrous, USP has been added to the 750-mg dose to adjust the osmolality. Sodium Citrate Hydrous, USP has been added as a buffer (300 mg and 600 mg to the 750-mg and 1.5-g doses, respectively). ZINACEF (cefuroxime) contains approximately 111 mg (4.8 mEq) and 222 mg (9.7 mEq) of sodium in the 750-mg and 1.5-g doses, respectively. The pH has been adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. Solutions of premixed ZINACEF (cefuroxime) range in color from light yellow to amber. The solution is intended for intravenous (IV) use after thawing to room temperature. The osmolality of the solution is approximately 300 mOsmol/kg, and the pH of thawed solutions ranges from 5 to 7.5.

The plastic container for the frozen solution is fabricated from a specially designed multilayer plastic, PL 2040. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue, culture toxicity studies.

What are the precautions when taking cefuroxime (Zinacef)?

Before using cefuroxime, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk and...

Read All Potential Precautions of Zinacef »

Zinacef Consumer (continued)

SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause loss of appetite, nausea, vomiting, diarrhea, irritability, or headache. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: dark urine, easy bruising/bleeding, fast/pounding/irregular heartbeat, seizures, unusual weakness, yellowing eyes/skin, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using cefuroxime, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Soliris

DRUG DESCRIPTION

Soliris, a complement inhibitor, is a formulation of eculizumab which is a
recombinant humanized monoclonal IgG2/4κ antibody produced by murine myeloma
cell culture and purified by standard bioprocess technology. Eculizumab contains
human constant regions from human IgG2 sequences and human IgG4 sequences and
murine complementarity-determining regions grafted onto the human framework
light- and heavy-chain variable regions. Eculizumab is composed of two 448 amino
acid heavy chains and two 214 amino acid light chains and has a molecular weight
of approximately 148 kDa.

Soliris is a sterile, clear, colorless, preservative-free 10 mg/mL solution
for intravenous infusion and is supplied in 30-mL single-use vials. The product
is formulated at pH 7 and each vial contains 300 mg of eculizumab, 13.8 mg sodium
phosphate monobasic, 53.4 mg sodium phosphate dibasic, 263.1 mg sodium chloride,
6.6 mg polysorbate 80 (vegetable origin) and Water for Injection, USP.

What are the possible side effects of eculizumab (Soliris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);


• stiffness in your neck or back;


• sensitivity to bright light;


• high fever (103 degrees or higher), chills, body aches, flu symptoms;


• any signs...

Read All Potential Side Effects and See Pictures of Soliris »

What are the precautions when taking eculizumab (Soliris)?

Before using eculizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current meningitis or other infection caused by the bacteria Neisseria meningitidis, no vaccination for meningitis.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have...

Read All Potential Precautions of Soliris »

Soliris Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, tiredness, nausea, or muscle pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using eculizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current meningitis or other infection caused by the bacteria Neisseria meningitidis, no vaccination for meningitis.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Soliris Patient Information Including Side Effects

Brand Names: Soliris

Generic Name: eculizumab (Pronunciation: E kue LIZ oo mab)

• What is eculizumab (Soliris)?


• What are the possible side effects of eculizumab (Soliris)?


• What is the most important information I should know about eculizumab (Soliris)?


• What should I discuss with my health care provider before taking eculizumab (Soliris)?


• How is eculizumab given (Soliris)?


• What happens if I miss a dose (Soliris)?


• What happens if I overdose (Soliris)?


• What should I avoid while taking eculizumab (Soliris)?


• What other drugs will affect eculizumab (Soliris)?


• Where can I get more information?

What is eculizumab (Soliris)?

Eculizumab is a monoclonal antibody that binds to proteins in the blood that can destroy red blood cells in people with a genetic condition that affects the natural defenses of red blood cells.

Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).

Eculizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of eculizumab (Soliris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);


• stiffness in your neck or back;


• sensitivity to bright light;


• high fever (103 degrees or higher), chills, body aches, flu symptoms;


• any signs of a new illness or injection; or


• signs that the medication is not working (pale skin, easy bruising, weakness, dark urine, feeling short of breath, or sudden numbness, severe headache, deep leg pain, or problems with vision, speech, or balance).

Less serious side effects may include:

• nausea;


• constipation;


• mild headache;


• runny nose, sore throat; or


• back pain.

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.

What is the most important information I should know about eculizumab (Soliris)?

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. Get emergency medical help if you have any signs of meningitis, such as severe headache with fever, confusion, purple spots on the skin, and/or seizure (convulsions) and nausea or vomiting, stiffness in your neck or back, sensitivity to bright light, or a very high fever (103 degrees or higher), chills, body aches, or other flu-like symptoms.

With your medication you will receive a Patient Safety Card listing the symptoms of meningitis. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.

You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. If you have been vaccinated in the past, you may need a booster dose. It is best to stay current on all of your vaccinations before you receive eculizumab, and your doctor may recommend other vaccines before or during treatment.

Related Drug Centers

• Soliris