Zyrtec

DRUG DESCRIPTION

Cetirizine hydrochloride, the active component of ZYRTEC® (cetirizine) tablets and syrup,
is an orally active and selective H₁-receptor antagonist. The chemical
name is (±) - [2- [4- [ (4-chlorophenyl)phenylmethyl] -1- piperazinyl]
ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound
with an empirical formula of C₂₁H₂₅C_lN₂O₃•2HCl.
The molecular weight is 461.82 and the chemical structure is shown below:

Cetirizine hydrochloride is a white, crystalline powder and is water soluble. ZYRTEC (cetirizine) tablets are formulated as white, film-coated, rounded-off rectangular shaped tablets for oral administration and are available in 5 and 10 mg strengths. Inactive ingredients are: lactose monohydrate; microcrystalline cellulose; colloidal silicon dioxide; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; and polyethylene glycol.

ZYRTEC (cetirizine) chewable tablets are formulated as purple round tablets for oral administration and are available in 5 and 10 mg strengths. Inactive ingredients of the chewable tablets are: acesulfame potassium; artificial grape flavor; betadex, NF; blue dye; colloidal silicon dioxide; lactose monohydrate; magnesium stearate; mannitol; microcrystalline cellulose; natural flavor; red dye (carmine).

ZYRTEC (cetirizine) syrup is a colorless to slightly yellow syrup containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the syrup are: banana flavor; glacial acetic acid; glycerin; grape flavor; methylparaben; propylene glycol; propylparaben; sodium acetate; sugar syrup; and water.

What are the possible side effects of cetirizine (All Day Allergy, All Day Allergy Children's, Indoor/Outdoor Allergy Relief, Zyrtec, Zyrtec Hives)?

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 this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;


• weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);


• severe restless feeling, hyperactivity;

...

Read All Potential Side Effects and See Pictures of Zyrtec »

What are the precautions when taking cetirizine (Zyrtec)?

Before taking cetirizine, tell your doctor or pharmacist if you are allergic to it; or to hydroxyzine; 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. Do not self-treat with this medication without consulting your doctor first if you have certain medical conditions such as: kidney disease, liver disease.

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

If you have hives and your doctor has prescribed cetirizine, or if...

Read All Potential Precautions of Zyrtec »

Zyrtec Consumer (continued)

SIDE EFFECTS: Drowsiness, tiredness, and dry mouth may occur. In children, stomach pain and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, 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.

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 cetirizine, tell your doctor or pharmacist if you are allergic to it; or to hydroxyzine; 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. Do not self-treat with this medication without consulting your doctor first if you have certain medical conditions such as: kidney disease, liver disease.

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

If you have hives and your doctor has prescribed cetirizine, or if you are considering using this drug to treat your own hives, tell your doctor immediately if you have any of these other symptoms because they may be signs of a more serious condition: hives that are an unusual color, hives that look bruised or blistered, hives that do not itch.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be at greater risk for side effects (e.g., drowsiness) while using this drug.

During pregnancy, this medication should be used only when clearly needed and as directed by your doctor. Discuss the risks and benefits with your doctor before taking this drug.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Zyrtec Patient Information Including Side Effects

Brand Names: All Day Allergy, All Day Allergy Children's, Indoor/Outdoor Allergy Relief, Zyrtec, Zyrtec Hives

Generic Name: cetirizine (Pronunciation: se TIR a zeen)

• What is cetirizine (Zyrtec)?


• What are the possible side effects of cetirizine (Zyrtec)?


• What is the most important information I should know about cetirizine (Zyrtec)?


• What should I discuss with my healthcare provider before taking cetirizine (Zyrtec)?


• How should I take cetirizine (Zyrtec)?


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


• What happens if I overdose (Zyrtec)?


• What should I avoid while taking cetirizine (Zyrtec)?


• What other drugs will affect cetirizine (Zyrtec)?


• Where can I get more information?

What is cetirizine (Zyrtec)?

Cetirizine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Cetirizine is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Cetirizine is also used to treat itching and swelling caused by chronic urticaria (hives).

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

What are the possible side effects of cetirizine (Zyrtec)?

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 this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;


• weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);


• severe restless feeling, hyperactivity;


• confusion;


• problems with vision; or


• urinating less than usual or not at all.

Less serious side effects may include:

• dizziness, drowsiness;


• tired feeling;


• dry mouth;


• sore throat, cough;


• nausea, constipation; or


• headache.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cetirizine (Zyrtec)?

Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of cetirizine.

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by cetirizine.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Related Drug Centers

• Zyrtec

Zenpep

DRUG DESCRIPTION

ZENPEP is a pancreatic enzyme preparation consisting of pancrelipase, an extract
derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme
classes, including porcine-derived lipases, proteases, and amylases.

Pancrelipase is a cream-colored powder. It is miscible in water and practically
insoluble or insoluble in alcohol and ether.

Each capsule for oral administration contains enteric-coated beads (1.8-1.9mm
for 3,000 and 5,000 USP units of lipase, 2.2-2.5mm for 10,000, 15,000 and 20,000
USP units of lipase).

The active ingredient evaluated in clinical trials is lipase. ZENPEP is dosed
by lipase units. Other active ingredients include protease and amylase.

Inactive ingredients in ZENPEP include colloidal silicon dioxide, croscarmellose
sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate,
microcrystalline cellulose, talc, and triethyl citrate and are contained in
hypromellose capsules. The imprinting red ink on the 3,000 capsules strength
contains, antifoam DC 1510, industrial methylated spirit, iron oxide red C.I.
77491-E172, n-butyl alcohol, shellac and soya lecithin.

3,000 USP units of lipase; 10,000 USP units of protease; 16,000 USP
units of amylase. Capsules have a white opaque cap and a white opaque body with
imprint “EURAND 3”. The shells contain carnauba wax or talc, carrageenan,
hypromellose, potassium chloride, titanium oxide, and water. The imprinting
blue ink on the capsules strengths 5,000, 10,000, 15,000 and 20,000 contains
dehydrated alcohol, FD&C Blue #2 aluminum lake C.I. 73015-E132, isopropyl
alcohol, n-butyl alcohol, propylene glycol, shellac and strong ammonia solution.

5,000 USP units of lipase; 17,000 USP units of protease; 27,000 USP
units of amylase. Capsules have a white opaque cap and a white opaque body with
imprint “EURAND 5”. The shells contain carnauba wax or talc, carrageenan,
hypromellose, potassium chloride, titanium oxide, and water.

10,000 USP units of lipase; 34,000 USP units of protease; 55,000 USP
units of amylase. Capsules have a yellow opaque cap and a white opaque body
with imprint “EURAND 10”. The shells contain carnauba wax or talc,
carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow
ferric oxide.

15,000 USP units of lipase; 51,000 USP units of protease; 82,000 USP
units of amylase. Capsules have a red opaque cap and a white opaque body with
imprint “EURAND 15”. The shells contain carnauba wax or talc, carrageenan,
hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water.

20,000 USP units of lipase; 68,000 USP units of protease; 109,000 USP
units of amylase. Capsules have a green opaque cap and a white opaque body with
imprint “EURAND 20”. The shells contain carnauba wax or talc, carrageenan,
FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and
yellow ferric oxide.

What are the possible side effects of pancrelipase?

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.

Less serious side effects may include:

• nausea or vomiting;


• stomach pain or upset;


• diarrhea or constipation;


• greasy stools;


• rectal irritation; or


• bloating or gas.

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...

Read All Potential Side Effects and See Pictures of Zenpep »

What are the precautions when taking pancrelipase delayed release capsules (Zenpep)?

Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; 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: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history.

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

It is not...

Read All Potential Precautions of Zenpep »

Zenpep Consumer (continued)

SIDE EFFECTS: Diarrhea, constipation, abdominal pain/cramps, nausea, or vomiting 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 immediately if any of these rare but very serious side effects occur: severe constipation, severe stomach/abdominal discomfort, frequent/painful urination, joint pain.

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 pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; 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: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history.

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.

Zenpep Patient Information Including Side Effects

Brand Names: Cotazym, Cotazym-S, Creon 10, Creon 20, Creon 5, Dygase, Kutrase, Ku-Zyme, Ku-Zyme HP, Lapase, Lipram, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Panokase, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Viokase 8

Generic Name: pancrelipase (oral) (Pronunciation: pan kre LYE pace)

• What is pancrelipase (Zenpep)?


• What are the possible side effects of pancrelipase?


• What is the most important information I should know about pancrelipase?


• What should I discuss with my healthcare provider before taking pancrelipase?


• How should I take pancrelipase?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while taking pancrelipase?


• What other drugs will affect pancrelipase?


• Where can I get more information?

What is pancrelipase (Zenpep)?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

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

What are the possible side effects of pancrelipase?

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.

Less serious side effects may include:

• nausea or vomiting;


• stomach pain or upset;


• diarrhea or constipation;


• greasy stools;


• rectal irritation; or


• bloating or gas.

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 pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

It is important to use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

Related Drug Centers

• Pancrecarb


• Ultrase


• Ultrase MT


• Creon


• Zenpep


• Creon 5


• Creon 10


• Creon 20


• Viokase

Prialt

DRUG DESCRIPTION

PRIALT contains ziconotide, a synthetic equivalent of a naturally occurring
conopeptide found in the piscivorous marine snail, Conus magus. Ziconotide
is a 25 amino acid, polybasic peptide containing three disulfide bridges with
a molecular weight of 2639 daltons and a molecular formula of C₁₀₂H₁₇₂N₃₆O₃₂S₇.
The amino acid sequence and disulfide bridging pattern are given below:

Ziconotide is a hydrophilic molecule that is freely soluble in water and is
practically insoluble in methyl t-butyl ether.

PRIALT is formulated as a sterile, preservative-free, isotonic solution for
intrathecal administration using an appropriate microinfusion device [see DOSAGE
AND ADMINISTRATION]. Each 1 or 5 mL vial of PRIALT (100 mcg/mL) respectively
contains 100 or 500 mcg of ziconotide acetate, and the 20 mL vial of PRIALT
(25 mcg/mL) contains 500 mcg of ziconotide acetate, with L-methionine and sodium
chloride as excipients at pH 4.0–5.0. Each vial is intended for single use only,
either undiluted or after dilution to the appropriate concentration with 0.9%
Sodium Chloride Injection, USP (preservative free).

What are the possible side effects of ziconotide (Prialt)?

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:

• problems with memory, speech, walking, or thinking;


• feeling like you might pass out;


• double vision or other vision problems;


• new or worsening muscle pain, cramps, soreness, or weakness, and/or dark urine;


• unusual bleeding or signs of infection around the...

Read All Potential Side Effects and See Pictures of Prialt »

What are the precautions when taking ziconotide (Prialt)?

Before using ziconotide, 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: uncontrolled bleeding, any infection near the injection site, mental/mood disorders (e.g., depression, psychosis, thoughts of suicide), spinal canal blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular/long-term use of narcotic medication.

This medication is not a narcotic (morphine-like drug). If...

Read All Potential Precautions of Prialt »

Prialt Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, nausea, headache, and weakness may occur. 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 right away if you have any serious side effects, including: decreased alertness (unresponsiveness), confusion, memory problems, mental/mood changes (e.g., anxiety, depression, hallucinations, thoughts of suicide), new or worsening muscle pain/soreness, numbness/tingling, trouble speaking/swallowing, difficult/unsteady walking, trouble urinating, dark urine, vision changes.

A very serious infection (meningitis) may occur if the site of your infusion or the solution going into your spinal cord becomes contaminated. Symptoms of meningitis include mental changes (e.g., extreme drowsiness, confusion), high fever, seizures, severe headache, stiff neck, nausea, and vomiting. Seek immediate medical attention if any of these unlikely but very serious side effects occur.

A very serious allergic reaction to this drug is unlikely, but get medical help right away 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 ziconotide, 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: uncontrolled bleeding, any infection near the injection site, mental/mood disorders (e.g., depression, psychosis, thoughts of suicide), spinal canal blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular/long-term use of narcotic medication.

This medication is not a narcotic (morphine-like drug). If you have been using a narcotic (e.g., codeine, hydrocodone, morphine) regularly for more than a few weeks, or if it has been used in high doses, you may be dependent on it. In such cases, if you suddenly stop the narcotic, withdrawal reactions may occur. This medication will not prevent withdrawal reactions from narcotics. When stopping extended, regular treatment with narcotics, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

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.

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

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

It is unknown if this medication passes into breast milk, and it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Prialt Patient Information Including Side Effects

Brand Names: Prialt

Generic Name: ziconotide (Pronunciation: zye KON oh tide)

• What is ziconotide (Prialt)?


• What are the possible side effects of ziconotide (Prialt)?


• What is the most important information I should know about ziconotide (Prialt)?


• What should I discuss with my healthcare provider before using ziconotide (Prialt)?


• How should I use ziconotide (Prialt)?


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


• What happens if I overdose (Prialt)?


• What should I avoid while using ziconotide (Prialt)?


• What other drugs will affect ziconotide (Prialt)?


• Where can I get more information?

What is ziconotide (Prialt)?

Ziconotide is a non-narcotic pain reliever that works by blocking pain signals from the nerves to the brain.

Ziconotide is used to treat severe chronic pain in people who cannot use or do not respond to standard pain-relieving medications.

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

What are the possible side effects of ziconotide (Prialt)?

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:

• problems with memory, speech, walking, or thinking;


• feeling like you might pass out;


• double vision or other vision problems;


• new or worsening muscle pain, cramps, soreness, or weakness, and/or dark urine;


• unusual bleeding or signs of infection around the microinfusion entry or catheter exit sites;


• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, nausea, vomiting, and/or seizure (convulsions);


• extreme drowsiness or tired feeling, depressed mood;


• feeling paranoid, hostile, disoriented, or confused;


• strange sensations in your mouth;


• hallucinations, unusual thoughts or behavior, thoughts of hurting yourself; or


• feeling less alert, decreased consciousness (stupor or lack of response).

Less serious side effects may include:

• headache, joint pain;


• mild drowsiness or weakness;


• dizziness, spinning sensation;


• sleep problems, unusual dreams;


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


• urinating less than usual; or


• loss of balance or coordination.

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 ziconotide (Prialt)?

Severe psychiatric symptoms and neurological impairment may occur during treatment with ziconotide. You should not receive ziconotide if you have a history of psychiatric illness or psychotic event.

You should not use this medication if you are allergic to ziconotide, or if you have an uncontrolled bleeding or blood clotting disorder.

Ziconotide must be given only as an intrathecal injection through an infusion pump and should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other healthcare provider will give you this injection.

Your doctor may occasionally change your dose or infusion pump flow rate to make sure you get the best results from this medication.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Tell your doctor if you regularly use other medicines that make you sleepy. Ziconotide can add to sleepiness caused by these other medications.

Call your doctor at once if you have a serious side effect, especially fever, neck stiffness, seizure (convulsions), extreme drowsiness or tired feeling, confusion, disorientation, hallucinations, thoughts of hurting yourself, or decreased consciousness.

Related Drug Centers

• Prialt

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.